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

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

Recruiting
12-25 years
All
Phase N/A

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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)

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.

Eligibility

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

Study details
    Stress
    Anxiety

NCT06038318

Dana-Farber Cancer Institute

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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