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Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IGCDG
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18
  • Diagnosed with stage IV breast cancer within the past 3 years
  • Receiving care at the MGH Cancer Center
  • Verbal and written fluency in English
  • Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen

Exclusion Criteria:

  • Unwilling or unable to participate in the study
  • Is medically or otherwise unable to participate (as determined by a physician or study PI)
  • Enrolled in hospice

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Survey QOL

Arm Description

Study participants will be provided with the Individualized Goals of Care Discussion Guide (IGCDG) consisting of a brief pamphlet and the IGCDG questionnaire. Participants will be asked to complete the IGCDG questionnaire prior to their next visit. Participants will also complete an 8-week follow-up survey after the clinic visit to evaluate the impact on patient satisfaction with care, communication, and care received.

Outcomes

Primary Outcome Measures

Recruitment rate
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the recruitment rate. Recruitment will be calculated as the number of patients who choose to participate divided by the number approached to enroll. A recruitment rate of greater than 50% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.
Attrition rate
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the attrition rate. Attrition will be calculated as the number of participants who to do not complete the follow-up survey divided by the number enrolled. An attrition rate of less than 32% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.
Change in distress
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the change in distress as measured by the NCCN distress thermometer between baseline administration and the 8-week follow-up survey. Lack of detection of a significant increase between baseline and follow-up distress scores among the participants will be interpreted as supporting feasibility. A significant increase in distress will be defined as >50% of participants having an increase in distress ≥3 between baseline and follow-up. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.

Secondary Outcome Measures

Evaluate baseline preferences for care among patients with metastatic breast cancer via the Individualized Goals of Care Discussion Guide (IGCDG) questionnaire
The IGCDG questionnaire reviews topics of concern for patients with metastatic breast cancer, such as goals of cancer treatment and priorities for discussions with the patient's clinician. This is a descriptive, study specific measure.
The Satisfaction with Decision Making Scale
This is a six item validated scale designed to measure patient satisfaction with medical decision making. Participants rate their level of agreement on a 5-point scale with statements regarding medical decision-making. (1 = strongly agree; 5 = strongly disagree) . Lower scores indicate higher inclusion of the patient in decision-making.
The Decisional Conflict Scale
This is a 16-item Likert scale with proven validity and reliability. Scores range from 1 to 5, with higher scores suggesting increased difficulty and conflict over decision making.
Modified Control Preferences Scale
This 2 question scale is used to measure a participant's desired and actual participation in decision-making. As in prior work, the investigators have collapsed responses into 3 choices: decisions are made mainly by the patient, decisions are made equally, and decisions are made mainly by the clinician. Analysis is based on comparison of the participants reported desired role in decision making and actual role, with greater concordance indicating decision making that is aligned with the participants preferences.
Patient Satisfaction with Cancer Care
The Patient Satisfaction with Cancer Care measure is a validated 18 item tool with responses on a 5 point Likert scale designed specifically to assess satisfaction among patients from diverse socio-demographic backgrounds. The investigators have modified the scale to remove 3 questions that were not relevant for this study population. Total score for this scale is calculated by adding all component scores, with lower scores indicating higher satisfaction with care.

Full Information

First Posted
November 6, 2017
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03375827
Brief Title
Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Official Title
Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Pfizer

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 research study is evaluating whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit helps improve communication and decision-making in breast cancer care.
Detailed Description
The purpose of this study is to understand patient preferences for communication and decision-making for advanced breast cancer. The investigators want to better understand what topics the participant wants their doctors and nurses to address with the participant in clinic, and the investigators want to evaluate whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit is a good idea that helps to improve communication and decision-making in breast cancer care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survey QOL
Arm Type
Experimental
Arm Description
Study participants will be provided with the Individualized Goals of Care Discussion Guide (IGCDG) consisting of a brief pamphlet and the IGCDG questionnaire. Participants will be asked to complete the IGCDG questionnaire prior to their next visit. Participants will also complete an 8-week follow-up survey after the clinic visit to evaluate the impact on patient satisfaction with care, communication, and care received.
Intervention Type
Other
Intervention Name(s)
IGCDG
Intervention Description
The IGCDG reviews topics of concern for patients with metastatic breast cancer.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the recruitment rate. Recruitment will be calculated as the number of patients who choose to participate divided by the number approached to enroll. A recruitment rate of greater than 50% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.
Time Frame
2 years
Title
Attrition rate
Description
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the attrition rate. Attrition will be calculated as the number of participants who to do not complete the follow-up survey divided by the number enrolled. An attrition rate of less than 32% will be deemed feasible. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.
Time Frame
2 years
Title
Change in distress
Description
The investigators will evaluate the primary hypothesis, that administration of the IGCDG in a breast oncology clinic is feasible, by evaluating the change in distress as measured by the NCCN distress thermometer between baseline administration and the 8-week follow-up survey. Lack of detection of a significant increase between baseline and follow-up distress scores among the participants will be interpreted as supporting feasibility. A significant increase in distress will be defined as >50% of participants having an increase in distress ≥3 between baseline and follow-up. Each of the 3 distinct components of feasibility (recruitment rate, attrition rate, and change in distress) must be met for the administration of the Individualized Goals of Care Discussion Guide to be deemed feasible.
Time Frame
8 weeks after the IGCDG was provided to participant's clinician
Secondary Outcome Measure Information:
Title
Evaluate baseline preferences for care among patients with metastatic breast cancer via the Individualized Goals of Care Discussion Guide (IGCDG) questionnaire
Description
The IGCDG questionnaire reviews topics of concern for patients with metastatic breast cancer, such as goals of cancer treatment and priorities for discussions with the patient's clinician. This is a descriptive, study specific measure.
Time Frame
baseline
Title
The Satisfaction with Decision Making Scale
Description
This is a six item validated scale designed to measure patient satisfaction with medical decision making. Participants rate their level of agreement on a 5-point scale with statements regarding medical decision-making. (1 = strongly agree; 5 = strongly disagree) . Lower scores indicate higher inclusion of the patient in decision-making.
Time Frame
8 weeks after the IGCDG was provided to participant's clinician
Title
The Decisional Conflict Scale
Description
This is a 16-item Likert scale with proven validity and reliability. Scores range from 1 to 5, with higher scores suggesting increased difficulty and conflict over decision making.
Time Frame
8 weeks after the IGCDG was provided to participant's clinician
Title
Modified Control Preferences Scale
Description
This 2 question scale is used to measure a participant's desired and actual participation in decision-making. As in prior work, the investigators have collapsed responses into 3 choices: decisions are made mainly by the patient, decisions are made equally, and decisions are made mainly by the clinician. Analysis is based on comparison of the participants reported desired role in decision making and actual role, with greater concordance indicating decision making that is aligned with the participants preferences.
Time Frame
8 weeks after the IGCDG was provided to participant's clinician
Title
Patient Satisfaction with Cancer Care
Description
The Patient Satisfaction with Cancer Care measure is a validated 18 item tool with responses on a 5 point Likert scale designed specifically to assess satisfaction among patients from diverse socio-demographic backgrounds. The investigators have modified the scale to remove 3 questions that were not relevant for this study population. Total score for this scale is calculated by adding all component scores, with lower scores indicating higher satisfaction with care.
Time Frame
8 weeks after the IGCDG was provided to participant's clinician

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 Diagnosed with stage IV breast cancer within the past 3 years Receiving care at the MGH Cancer Center Verbal and written fluency in English Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen Exclusion Criteria: Unwilling or unable to participate in the study Is medically or otherwise unable to participate (as determined by a physician or study PI) Enrolled in hospice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Peppercorn, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer

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