Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
Purpose
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)
Conditions
- Stress
- Anxiety
Eligibility
- Eligible Ages
- Between 12 Years and 25 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
Detailed 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.
