Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
Primary Purpose
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-Based Intervention
Best Practice
Questionnaire Administration
Sponsored by
About this trial
This is an interventional health services research trial for Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 focused on measuring Advance Care Planning, Advance Directives, End-of-Life, Cancer
Eligibility Criteria
Inclusion Criteria:
- PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.
- PATIENT: Access to a mobile device; the principal investigator (PI) will ensure that those who have access to a mobile device have access to a mobile device with internet access to ensure they can complete study procedures.
- PATIENT: The ability to provide informed consent.
- PATIENT: Identification of and enrollment a loved one/informal caregiver.
- CAREGIVER: The person (family member or friend) whom the patient indicates being an informal caregiver.
- CAREGIVER: English speaking.
- CAREGIVER: 18 years of age or older.
- CAREGIVER: Able to provide informed consent.
- PROVIDER: Current clinical practice and/or research with advanced cancer patients.
- PROVIDER: A history of 3+ years working with advanced cancer patients.
- PROVIDER: 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled.
Exclusion Criteria:
- PATIENT: Not fluent in English.
- PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6 to be delivered by trained study research staff during screening).
- PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
- PATIENT: Currently receiving hospice at the time of enrollment.
- PATIENT: Children and young adults under age 18.
Sites / Locations
- Northwell Health
- Mount Sinai Hospital
- NYP/Weill Cornell Medical Center
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (PACT)
Arm II (standard care)
Arm Description
Participants use PACT mHealth app.
Participants engage in standard care with no modifications.
Outcomes
Primary Outcome Measures
Feasibility: Accrual rates [Patients]
Will assess the percentage of eligible approached patients who consent to enroll in the study
Feasibility: Accrual rates [Caregivers]
Will assess the percentage of eligible approached caregivers who consent to enroll in the study
Feasibility: Rates of intervention completion [Patients]
Will assess the percentage of enrolled patients who complete the intervention
Feasibility: Rates of intervention completion [Caregivers]
Will assess the percentage of enrolled caregivers who complete the intervention
Acceptability of the PACT application: Acceptability E-Scale [Patients]
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Acceptability of the PACT application: Acceptability E-Scale [Caregivers]
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Usability of the PACT application: System Usability Scale (SUS) [Patients]
Usability of the PACT application will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Usability of the PACT application: System Usability Scale (SUS) [Caregivers]
Usability of the PACT application will be assessed among caregivers using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
User satisfaction [Patients]
User satisfaction: Patients will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
User satisfaction [Caregivers]
User satisfaction: Caregivers will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
User engagement as measured by number of views [Patients]
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by number of views [Caregivers]
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
User engagement as measured by time spent on app [Patients]
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
User engagement as measured by time spent on app [Caregivers]
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Change in level of engagement in advance care planning [Patients]
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Patients]
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Caregivers]
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in level of engagement in advance care planning [Caregivers]
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Change in documentation of advance care planning conversations [Patients]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Change in documentation of advance care planning conversations [Patients]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Change in documentation of advance care planning conversations [Caregivers]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Change in documentation of advance care planning conversations [Caregivers]
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Change in completion of advance directives
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Change in completion of advance directives
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Secondary Outcome Measures
Change in treatment preference
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Change in treatment preference
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Change in healthcare utilization (summary score for total number of healthcare services utilized)
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Change in healthcare utilization (summary score for total number of healthcare services utilized)
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Change in number of subjects receiving goal-concordant care
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Change in number of subjects receiving goal-concordant care
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Change in perceived social support
This will be assessed among patients and caregivers using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Change in perceived social support
This will be assessed among patients and caregivers using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Change in family functioning
This will be assessed among patients and caregivers using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Change in family functioning
This will be assessed among patients and caregivers using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Full Information
NCT ID
NCT04515810
First Posted
August 12, 2020
Last Updated
April 12, 2023
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04515810
Brief Title
Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
Official Title
Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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 tests a new mobile health application (app) called Planning Advance Care Together (PACT) to help people with cancer talk about and plan for advance care planning (the care they would want if they were unable to communicate) with their loved ones and doctors. The development of the PACT mobile app may help future patients incorporate their social network (typically, but not exclusively, family) into the advance care planning process.
Detailed Description
OUTLINE: Patients and caregivers are randomized to 1 of 2 arms.
ARM I: Participants use PACT mHealth app.
ARM II: Participants engage in standard care with no modifications.
After completion of study intervention, participants are followed up at 3 and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Locally Advanced Hepatocellular Carcinoma, Locally Advanced Lung Carcinoma, Locally Advanced Malignant Female Reproductive System Neoplasm, Locally Advanced Pancreatobiliary Carcinoma, Malignant Solid Neoplasm, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Hepatocellular Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm, Metastatic Pancreatobiliary Carcinoma, Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8, Refractory Gastroesophageal Junction Adenocarcinoma, Refractory Hepatocellular Carcinoma, Refractory Lung Carcinoma, Refractory Malignant Female Reproductive System Neoplasm, Refractory Pancreatobiliary Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8, Stage IVB Lung Cancer AJCC v8
Keywords
Advance Care Planning, Advance Directives, End-of-Life, Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (PACT)
Arm Type
Experimental
Arm Description
Participants use PACT mHealth app.
Arm Title
Arm II (standard care)
Arm Type
Active Comparator
Arm Description
Participants engage in standard care with no modifications.
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Use smartphone application
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Engage in standard care
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility: Accrual rates [Patients]
Description
Will assess the percentage of eligible approached patients who consent to enroll in the study
Time Frame
At 3 months post-randomization
Title
Feasibility: Accrual rates [Caregivers]
Description
Will assess the percentage of eligible approached caregivers who consent to enroll in the study
Time Frame
At 3 months post-randomization
Title
Feasibility: Rates of intervention completion [Patients]
Description
Will assess the percentage of enrolled patients who complete the intervention
Time Frame
At 3 months post-randomization
Title
Feasibility: Rates of intervention completion [Caregivers]
Description
Will assess the percentage of enrolled caregivers who complete the intervention
Time Frame
At 3 months post-randomization
Title
Acceptability of the PACT application: Acceptability E-Scale [Patients]
Description
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Time Frame
At 3 months post-randomization
Title
Acceptability of the PACT application: Acceptability E-Scale [Caregivers]
Description
The Acceptability E-Scale is a 6-item scale, scored on a 5-point Likert scale (e.g., 1=very difficult; 5= very easy), with previously demonstrated good internal consistency (Cronbach's alpha=.76), with higher values indicating higher levels of acceptability.
Time Frame
At 3 months post-randomization
Title
Usability of the PACT application: System Usability Scale (SUS) [Patients]
Description
Usability of the PACT application will be assessed among patients using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Time Frame
At 3 months post-randomization
Title
Usability of the PACT application: System Usability Scale (SUS) [Caregivers]
Description
Usability of the PACT application will be assessed among caregivers using the System Usability Scale (SUS). The SUS is a 10-item scale, scored on a 5-point Lilkert scale (1=strongly disagree; 5=strongly agree), with higher values indicating higher levels of usability
Time Frame
At 3 months post-randomization
Title
User satisfaction [Patients]
Description
User satisfaction: Patients will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
Time Frame
At 3 months post-randomization
Title
User satisfaction [Caregivers]
Description
User satisfaction: Caregivers will engage in an exit interview that assesses their overall satisfaction with the app on a Likert scale ranging from 1-10 (1=not at all satisfied; 10 = extremely satisfied), with higher values indicating higher levels of satisfaction
Time Frame
At 3 months post-randomization
Title
User engagement as measured by number of views [Patients]
Description
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
Time Frame
Baseline to 3 months post-intervention
Title
User engagement as measured by number of views [Caregivers]
Description
User engagement will be assessed through tracking of activity (i.e., number of views) over a 3-month period following randomization.
Time Frame
Baseline to 3 months post-intervention
Title
User engagement as measured by time spent on app [Patients]
Description
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Time Frame
Baseline to 3 months post-intervention
Title
User engagement as measured by time spent on app [Caregivers]
Description
User engagement will be assessed through tracking of activity (i.e., time spent on app) over a 3-month period following randomization.
Time Frame
Baseline to 3 months post-intervention
Title
Change in level of engagement in advance care planning [Patients]
Description
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Time Frame
Baseline to 3 months post-intervention
Title
Change in level of engagement in advance care planning [Patients]
Description
Patients will be assessed using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Time Frame
Baseline to 6 months post-intervention
Title
Change in level of engagement in advance care planning [Caregivers]
Description
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Time Frame
Baseline to 3 months post-intervention
Title
Change in level of engagement in advance care planning [Caregivers]
Description
Caregivers will be assessed using an adapted caregiver version of the reliable and valid Advance Care Planning Engagement Survey: Action Measures. This scale is composed of four sub scales with a total of 18 items. All items are rated on a yes=1 and no=0. Scores can range from 0 (no action taken) to 18 (all actions taken).
Time Frame
Baseline to 6 months post-intervention
Title
Change in documentation of advance care planning conversations [Patients]
Description
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Time Frame
Baseline to 3 months post-intervention
Title
Change in documentation of advance care planning conversations [Patients]
Description
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with family and doctor (all yes/no questions).
Time Frame
Baseline to 6 months post-intervention
Title
Change in documentation of advance care planning conversations [Caregivers]
Description
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Time Frame
Baseline to 3 months post-intervention
Title
Change in documentation of advance care planning conversations [Caregivers]
Description
This will be measured using our previously utilized 8-item measure of discussing EoL care, living will, HCP, and DNR orders with patient and patient's doctor) (all yes/no questions).
Time Frame
Baseline to 6 months post-intervention
Title
Change in completion of advance directives
Description
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Time Frame
Baseline to 3 months post-intervention
Title
Change in completion of advance directives
Description
This will be assessed by asking patients whether they have completed a Do Not Resuscitate order (DNR), living will, or identified a Health Care Proxy (HCP). All yes/no questions.
Time Frame
Baseline to 6 months post-intervention
Secondary Outcome Measure Information:
Title
Change in treatment preference
Description
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Time Frame
Baseline to 3 months
Title
Change in treatment preference
Description
This will be assessed in patients with an item used previously in our team's NCI-funded cohort studies that asks patients to express a preference for life-extending versus comfort care (two answer choices).
Time Frame
Baseline to 6 months
Title
Change in healthcare utilization (summary score for total number of healthcare services utilized)
Description
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Time Frame
Baseline to 3 months
Title
Change in healthcare utilization (summary score for total number of healthcare services utilized)
Description
This measure will assess patients' receipt of life-prolonging care (number of emergency room visits, hospital admissions, length of stay in the hospital, rates of ICU admission) and use of palliative or hospice care (length and duration of palliative and/or hospice care). A total score will be created for healthcare utilization.
Time Frame
Baseline to 6 months
Title
Change in number of subjects receiving goal-concordant care
Description
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Time Frame
Baseline to 3 months
Title
Change in number of subjects receiving goal-concordant care
Description
This will be determined by comparing patients' treatment preferences to treatment received. Patients matching on their desired and received care will be designated as having received goal-concordant care.
Time Frame
Baseline to 6 months
Title
Change in perceived social support
Description
This will be assessed among patients and caregivers using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Time Frame
Baseline to 3 months
Title
Change in perceived social support
Description
This will be assessed among patients and caregivers using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item valid and reliable measure of social support from family, friends, and significant other, scored on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), with previously reported excellent internal reliability (Cronbach's α = 0.84 to 0.92).
Time Frame
Baseline to 6 months
Title
Change in family functioning
Description
This will be assessed among patients and caregivers using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Time Frame
Baseline to 3 months
Title
Change in family functioning
Description
This will be assessed among patients and caregivers using the Family Relationship Index (FRI), a scale derived from the Family Environment Scale. FRI consists of 12 true/false items consisting of three subscales (cohesiveness, expressiveness, and conflict resolution) with scores ranging from 1 to 4 with higher scores indicating better family functioning. The FRI is well-validated in cancer patients.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PATIENT: Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy.
PATIENT: Access to a mobile device; the principal investigator (PI) will ensure that those who have access to a mobile device have access to a mobile device with internet access to ensure they can complete study procedures.
PATIENT: The ability to provide informed consent.
PATIENT: Identification and enrollment of a loved one/informal caregiver.
PATIENT: 18 years of age or older.
CAREGIVER: The person (family member or friend) whom the patient indicates being an informal caregiver.
CAREGIVER: English speaking.
CAREGIVER: 18 years of age or older and able to provide informed consent.
Exclusion Criteria:
PATIENT: Not fluent in English.
PATIENT: Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of >= 6) to be delivered by trained study research staff during screening.
PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer).
PATIENT: Currently receiving hospice at the time of enrollment.
PATIENT: Children and young adults under age 18.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia De Los Santos, B.S.
Phone
206-667-1565
Email
cdelossa@fredhutch.org
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Shen, PhD
Phone
206-667-4172
Email
mshen2@fredhutch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan J Shen, PhD
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel McFarland
Phone
212-434-4552
Email
dmcfarland@northwell.edu
First Name & Middle Initial & Last Name & Degree
Daniel McFarland
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Miller
Phone
212-824-7783
Email
sarah.miller@mssm.edu
First Name & Middle Initial & Last Name & Degree
Sarah Miller
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Prigerson
Phone
646-962-9655
Email
hgp2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Holly Prigerson
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
Claudia De Los Santos, B.S.
Phone
206-667-1565
Email
cdelossa@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Megan J Shen, PhD
Phone
206-667-4172
Email
mshen2@fredhutch.org
First Name & Middle Initial & Last Name & Degree
Megan J Shen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
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Links:
URL
https://www.usability.gov/how-to-and-tools/methods/system-usability-scale.html
Description
Usability.gov. System Usability Scale (SUS)
URL
https://measuringu.com/sus/
Description
Measuring Usability with the System Usability Scale
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Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning
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