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Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer

Primary Purpose

Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Internet-Based Intervention
Questionnaire Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line chemotherapy
  • Clinician estimated prognosis of =< 12 months
  • Access to a computer or mobile device
  • The ability to provide informed consent

Exclusion Criteria:

  • Not fluent in English
  • Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6)
  • Too ill or weak to complete the interviews (as judged by the interviewer)

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (Peacefully's)

Group II (standard of care)

Arm Description

Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.

Patients receive standard care.

Outcomes

Primary Outcome Measures

Accrual
The number of participants enrolled during the recruitment period.
Retention rates
The number of participants who completed all study activities.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 4 weeks post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 12 weeks post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 24 weeks post-randomization
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 4 weeks post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 12 weeks post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 24 weeks post-randomization
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Change in advance care planning engagement: completion of advance directives, from baseline to 4 weeks post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Change in advance care planning engagement: completion of advance directives, from baseline to 12 weeks post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Change in advance care planning engagement: completion of advance directives, from baseline to 24 weeks post-randomization
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

Secondary Outcome Measures

Change in comprehensive end-of-life planning, from baseline to 4 weeks post-randomization
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Change in comprehensive end-of-life planning, from baseline to 12 weeks post-randomization
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Change in comprehensive end-of-life planning, from baseline to 24 weeks post-randomization
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 4 weeks post-randomization
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 12 weeks post-randomization
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 24 weeks post-randomization
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 4 weeks post-randomization
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 12 weeks post-randomization
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 24 weeks post-randomization
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 4 weeks post-randomization
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 12 weeks post-randomization
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 24 weeks post-randomization
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), from baseline to 4 weeks post-randomization
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 12 weeks post-randomization
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 24 weeks post-randomization
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 4 weeks post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 12 weeks post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 24 weeks post-randomization
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.

Full Information

First Posted
September 29, 2022
Last Updated
August 31, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute of Nursing Research (NINR), Peacefully, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05564468
Brief Title
Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer
Official Title
Design and Testing of a Web-Based Tool to Improve End-of-Life Planning Among Advanced Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Institute of Nursing Research (NINR), Peacefully, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). It is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization. Group I (intervention): Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7. Group II (control): Patients receive standard of care. After completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Peacefully's)
Arm Type
Experimental
Arm Description
Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Receive Peacefully's end-of-life planning program
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Accrual
Description
The number of participants enrolled during the recruitment period.
Time Frame
Up to 36 months
Title
Retention rates
Description
The number of participants who completed all study activities.
Time Frame
Up to 36 months
Title
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in patients' engagement in advance care planning, as measured by the Decision Maker subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., "Have you already decided who you want your medical decision maker to be?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 4 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 12 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in patients' engagement in advance care planning, as measured by the Quality of Life subscale of the Advance Care Planning Engagement Survey: Action Measures, from baseline to 24 weeks post-randomization
Description
Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., "Have you already decided whether or not certain health situations would make your life not worth living?" Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 4 weeks post-randomization
Description
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 12 weeks post-randomization
Description
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with family members and loved ones, from baseline to 24 weeks post-randomization
Description
Engagement in ACP with family members and loved ones will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the family subscale are computed by summing together the total number of ACP topic discussed with the patient's family members and loved ones. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with family members and loved ones.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 4 weeks post-randomization
Description
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 12 weeks post-randomization
Description
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in advance care planning engagement: conversations discussing EoL care, living will, HCP, and DNR orders with doctors, from baseline to 24 weeks post-randomization
Description
Engagement in ACP with doctors will be assessed in patients. This outcome will consist of documentation of ACP conversations using the investigators' previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family (4 items) and doctors (4 items). Scores for the doctor subscale are computed by summing together the total number of ACP topic discussed with the patient's doctors. Scores can range from 0 to 4, with higher scores indicating increases in engagement in ACP conversations with doctors.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in advance care planning engagement: completion of advance directives, from baseline to 4 weeks post-randomization
Description
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in advance care planning engagement: completion of advance directives, from baseline to 12 weeks post-randomization
Description
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in advance care planning engagement: completion of advance directives, from baseline to 24 weeks post-randomization
Description
Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.
Time Frame
Baseline and Week 24 post-randomization
Secondary Outcome Measure Information:
Title
Change in comprehensive end-of-life planning, from baseline to 4 weeks post-randomization
Description
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in comprehensive end-of-life planning, from baseline to 12 weeks post-randomization
Description
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in comprehensive end-of-life planning, from baseline to 24 weeks post-randomization
Description
Will be measured using a 15-item checklist of all completed tasks from the checklists/tasks on the website (eg, gather important documents, create a will). Scores are computed by summing together the total number of planning items completed. Scores can range from 0 to 15, with higher scores indicating increases in completion of end-of-life planning tasks. Change scores can range from -15 to +15.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 4 weeks post-randomization
Description
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 12 weeks post-randomization
Description
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in psychological distress, as measured by the Hospital Anxiety and Depression Scale (HADS), from baseline to 24 weeks post-randomization
Description
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-randomization.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 4 weeks post-randomization
Description
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 12 weeks post-randomization
Description
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in emotional well-being, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G) scale, from baseline to 24 weeks post-randomization
Description
Emotional well-being will be measured using the emotional well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 6 measure emotional well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the emotional well-being subscale can range from 6 to 30. Change in emotional well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 4 weeks post-randomization
Description
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 12 weeks post-randomization
Description
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in social/family well-being, as measured by the Functional Assessment of Cancer Therapy-General scale, from baseline to 24 weeks post-randomization
Description
Social well-being will be measured using the social well-being subscale of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) scale. The FACT-G scale contains 27 items, of which 7 measure social/family well-being. Items on the FACT-G ask patients to rate the degree to which they agree to statements about their well-being. Each item on this scale is rated on a 5-point Likert scale (1 = not at all, 5 = very much), with higher scores indicating better well-being. Total scores for the social/family well-being subscale can range from 6 to 35. Change in social/family well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp), from baseline to 4 weeks post-randomization
Description
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 12 weeks post-randomization
Description
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in spiritual well-being, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, from baseline to 24 weeks post-randomization
Description
Spiritual well-being will be measured using the validated, 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp). The FACIT-Sp asks patients to indicate the degree to which they agree with statements about their spiritual well-being. Each item on this scale is rated on a 5-point Likert scale (0 = not at all, 4 = very much), with higher scores indicating greater spiritual well-being. Total scores range from 0 to 48. Change in spiritual well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 24 post-randomization
Title
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 4 weeks post-randomization
Description
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 4 post-randomization
Title
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 12 weeks post-randomization
Description
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 12 post-randomization
Title
Change in financial well-being, as measured by the InCharge Financial Distress/Financial Well-Being scale, from baseline to 24 weeks post-randomization
Description
Financial well-being will be measured using the validated, 8-item InCharge Financial Distress/Financial Well-Being scale. This scale asks patients to rate their financial wellness (stress, satisfaction, etc.) on a 10-point Likert scale that varies for each response but for which 1 indicates the lowest financial well-being and 10 indicates the highest (e.g., 1=overwhelming stress to 10 = not stress at all; 1 = worry all the time, 10 - never worry). Total scores range from 8 to 80, with higher scores indicating greater financial well-being. Change in financial well-being will be assessed at baseline and 4 weeks post-randomization.
Time Frame
Baseline and Week 24 post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line chemotherapy Clinician estimated prognosis of =< 12 months Access to a computer or mobile device The ability to provide informed consent Exclusion Criteria: Not fluent in English Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6) Too ill or weak to complete the interviews (as judged by the interviewer)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan J. Shen
Phone
206-667-4172
Email
mshen2@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan J. Shen
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan J. Shen
Phone
206-667-4172
Email
mshen2@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Megan J. Shen

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer

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