Mobile Health Application (PACT) to Improve Engagement in Advance Care Planning

Study Overview
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Brief Summary
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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
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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.

Official Title
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Planning Advance Care Together (PACT) to Improve Engagement in Advance Care Planning

Conditions
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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

Intervention / Treatment
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* Other: Internet-Based Intervention
* Other: Best Practice
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (PACT)<br>Participants use PACT mHealth app. | Other: Internet-Based Intervention<br>* Use smartphone application<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (standard care)<br>Participants engage in standard care with no modifications. | Other: Best Practice<br>* Engage in standard care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Accrual rates [Patients] | Will assess the percentage of eligible approached patients who consent to enroll in the study | At 3 months post-randomization | 
| Feasibility: Accrual rates [Caregivers] | Will assess the percentage of eligible approached caregivers who consent to enroll in the study | At 3 months post-randomization | 
| Feasibility: Rates of intervention completion [Patients] | Will assess the percentage of enrolled patients who complete the intervention | At 3 months post-randomization | 
| Feasibility: Rates of intervention completion [Caregivers] | Will assess the percentage of enrolled caregivers who complete the intervention | At 3 months post-randomization | 
| 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. | At 3 months post-randomization | 
| 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. | At 3 months post-randomization | 
| 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 | At 3 months post-randomization | 
| 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 | At 3 months post-randomization | 
| 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 | At 3 months post-randomization | 
| 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 | At 3 months post-randomization | 
| 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. | Baseline to 3 months post-intervention | 
| 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. | Baseline to 3 months post-intervention | 
| 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. | Baseline to 3 months post-intervention | 
| 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. | Baseline to 3 months post-intervention | 
| 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). | Baseline to 3 months post-intervention | 
| 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). | Baseline to 6 months post-intervention | 
| 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). | Baseline to 3 months post-intervention | 
| 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). | Baseline to 6 months post-intervention | 
| 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). | Baseline to 3 months post-intervention | 
| 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). | Baseline to 6 months post-intervention | 
| 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). | Baseline to 3 months post-intervention | 
| 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). | Baseline to 6 months post-intervention | 
| 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. | Baseline to 3 months post-intervention | 
| 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. | Baseline to 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to 3 months | 
| 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). | Baseline to 6 months | 
| 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. | Baseline to 3 months | 
| 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. | Baseline to 6 months | 
| 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. | Baseline to 3 months | 
| 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. | Baseline to 6 months | 
| 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). | Baseline to 3 months | 
| 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). | Baseline to 6 months | 
| 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. | Baseline to 3 months | 
| 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. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Care Planning, Advance Directives, End-of-Life, Cancer