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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06038318
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Stress

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • PRISM Program Video Coach — BEHAVIORAL
    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 Coach — BEHAVIORAL
    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 App — BEHAVIORAL
    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.

Study Details

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)

Key Dates

Start date
Oct 16, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
May 1, 2027

Study Design

Enrollment
325 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: PRISM Program Mobile App
    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.
  • Active Comparator: PRISM Program Video Coach
    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.
  • Active Comparator: PRISM Program Text Coach
    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.

Primary Outcome Measure

Connor Davidson Resilience Scale (CDRISC-10) Score [ Time Frame: At 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02215
Abby Rosenberg, MD
[email protected]
206-987-6892
Abby Rosenberg, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Abby Rosenberg, MD
[email protected]
206-987-6892
Abby Rosenberg, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Children's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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