Videos for Advance Care Planning in Young Adults

Study Overview
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Brief Summary
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This study is a randomized trial of adolescent and young adults with advanced cancer and their caregivers to assess preferences for care in advanced cancer. This research study is examining the similarities and differences between patient's and caregiver's goals of cancer care. The names of the study interventions involved in this study may include: Questionnaires Video Phone Interview

Detailed Description
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The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. - Patients and their caregivers will be randomized into the same group; either ACP video decision aid intervention or usual care. Patients' and caregivers' knowledge, preferences (goals of care, CPR, ventilation), and decisional conflict be assessed before and after the ACP video decision aid intervention or usual care. Participants will be in this research study for up to 3 months with only 2 study visits. It is expected that about 100 people (50 patients and 50 caregivers) will take part in this research study.

Official Title
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Videos for Advance Care Planning in Young Adults

Conditions
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Advanced Cancer

Intervention / Treatment
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* Behavioral: ACP video decision aid
* Other: Usual Care-


Participation Criteria
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Eligibility Criteria
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All patients will be recruited from the outpatient clinics of Dana-Farber Cancer Institute (both pediatric and adult clinics),the inpatient settings of Boston Children's Hospital and Brigham and Women's Hospital, the inpatient or outpatient clinics of Massachusetts General Hospital, or virtually. Eligible study participants will give written consent to the primary investigator or study staff member before initiation of study procedures if recruited in-person. If participants are enrolled and complete study procedures virtually, they will provide verbal consent before initiating study procedures. If in-person visits cannot be conducted, eligible participants will be still be mailed a pre-notice letter that offers the chance for participants to opt-out or opt-in via email or phone call. After one week, we will call participants we have not heard from and ask if they would consider participating. Patient Eligibility criteria will include patients who are: i) Diagnosed with advanced cancer (i.e., initial first-line therapy is unsuccessful, marked by progression or relapsed disease) ii) Aged between 18-39, which is the legal age for completing an ACP document (e.g., POLST/MOLST); iii) Speak English; and iv) Have a caregiver or identified surrogate decision maker who is able to participate. v) Treated at Dana-Farber Cancer Institute or Massachusetts General Hospital Exclusion criteria will include: i) A diagnosis of low-grade glioma given the fact that progressive or relapsed low grade may not be clinically characterized as advanced disease and associated poor prognosis. ii) Visually impaired (note, hearing impaired is not an exclusion as the video is closed captioned); iii) Psychological state not appropriate for ACP discussions as determined by the primary oncologist; and, iv) Unable to participate in ACP discussions due to mental incapacity as determined by the Short Portable Mental Status Questionnaire

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACP video decision aid<br>The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care 10 minute video decision aid: describing the goals-of-care options . Follow telephone interview at 3 months | Behavioral: ACP video decision aid<br>* 10 minute video decision aid describing the goals-of-care options<br>|
| Active Comparator: Standard Care<br>The research study procedures include: screening for eligibility and study interventions including questionnaires and follow up visits. In-person interview where the patient and caregiver together will randomized to either the video aid intervention or standard care Receive the verbal description of the three types of care Follow telephone interview at 3 months | Other: Usual Care-<br>* Verbal description of the three types of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Concordance Rate | AYA with advanced cancer and caregivers randomized to the video will have higher concordance between patients and caregivers | baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Advance Care Planning (ACP) Conversations | Patients randomized to the video will have more ACP conversations and documentation after 3 months. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Cancer