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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Anxiety; Stress

Treatments: Behavioral: PRISM Program Text Coach; Behavioral: PRISM Program Video Coach; Behavioral: mPRISM Program App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06038318

22-652

R01CA269574-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 325 estimated patients

Sex: All

Ages: 12 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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325 participants in 3 patient groups

PRISM Program Mobile App

Experimental group

Description:

Participants will be randomized to "app-only" group and will complete: * Baseline questionnaire. * mPRISM App self guided modules * 3 month questionnaire. * mPRISM App self guided modules until final survey at 6 months and end of participation.

Treatment:

Behavioral: mPRISM Program App

PRISM Program Video Coach

Active Comparator group

Description:

Participants will be randomized to "video" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

Treatment:

Behavioral: mPRISM Program App

Behavioral: PRISM Program Video Coach

PRISM Program Text Coach

Active Comparator group

Description:

Participants will be randomized to "text" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.

Treatment:

Behavioral: mPRISM Program App

Behavioral: PRISM Program Text Coach