Intervention for adolescents and young adults with cancer to improve social health
The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
This study is testing a new program to help young people recently diagnosed with cancer improve their social skills and overall well-being compared to regular support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06242964 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and acceptability of the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention for adolescents and young adults (AYAs) newly diagnosed with cancer. Participants will be randomly assigned to receive either usual psychosocial care or the PRISM-SN program, which includes skill-based behavioral modules designed to enhance social functioning. The effectiveness of the intervention will be assessed through patient-reported outcome surveys at enrollment and after 12 weeks. The study seeks to determine if the PRISM-SN program leads to improved psychosocial outcomes compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 12-25 who have been newly diagnosed with cancer and are undergoing chemotherapy and/or radiation.
Not a fit: Patients with recurrent malignancies or those who are not currently receiving chemotherapy or radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the social and psychological well-being of young cancer patients.
How similar studies have performed: Other studies have shown promise in psychosocial interventions for cancer patients, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 12-25 years * Diagnosed with new malignancy treated with chemotherapy and/or radiation \<6-months * Able to speak in the English language * Able to read in the English language * Cognitively able to participate in intervention sessions and complete surveys Exclusion Criteria: * Aged \<12 or \>25 years * Diagnosed with recurrent malignancy * Diagnosed with new malignancy \>6 months * Not receiving chemotherapy and/or radiation * Not able to speak in the English language * Not able to read in the English language * Not cognitively able to participate in intervention session or complete surveys
Where this trial is running
Seattle, Washington
- Seattle Children's — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Kaitlyn M Fladeboe, PhD — Seattle Children's Hospital
- Study coordinator: Kaitlyn M Fladeboe, PhD
- Email: katy.fladeboe@seattlechildrens.org
- Phone: 2068844140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.