Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer

Dana-Farber Cancer Institute325 enrolled

Overview

The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is: -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)

In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams. In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized. The research study procedures include screening for eligibility and completion of questionnaires. Participation in this research study is expected to last for up to 6 months. It is expected about 325 people will take part in this research study. The National Institute for Health (NIH) is funding this research study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Interventions

PRISM Program Video CoachBEHAVIORAL

A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.

PRISM Program Text CoachBEHAVIORAL

A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.

mPRISM Program AppBEHAVIORAL

6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

Participants that have completed their main cancer-directed therapy at one of the study sites affiliated centers who meet all the eligibility criteria will be eligible for participation in this study. Inclusion Criteria: * All genders ≥ 12 and ≤ 25 years of age at baseline * Participant is able to speak English or Spanish language (for PRISM sessions) * Participant is able to read English or Spanish language (for completion of surveys) * Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator

Outcomes

Primary Outcomes

Connor Davidson Resilience Scale (CDRISC-10) Score

Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.

Time frame: At 6 months

Secondary Outcomes

CDRISC-10 Score for App-Only Cohort Responders

Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores \>29 after PRISM sessions or increased by \>2 points at the timepoints.

Time frame: 3 months

CDRISC-10 Score for Text Coach Cohort Responders

Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores \>29 after PRISM sessions or increased by \>2 points at the timepoints.

Time frame: 3 months

Change in HOPE Scale Score

Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 "Definitely False" to 8 "Definitely True" for a total score of 96. A higher score implies a greater level of hopeful thought patterns.