NCT06242964 The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
| NCT ID | NCT06242964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Children's Hospital |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-15 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback. 2. Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care. Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.
Eligibility 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
Contact & Investigator
Kaitlyn M Fladeboe, PhD
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT06242964 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 25 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06242964 currently recruiting?
Yes, NCT06242964 is actively recruiting participants. Contact the research team at katy.fladeboe@seattlechildrens.org for enrollment information.
Where is the NCT06242964 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06242964 clinical trial?
NCT06242964 is sponsored by Seattle Children's Hospital. The principal investigator is Kaitlyn M Fladeboe, PhD at Seattle Children's Hospital. The trial plans to enroll 100 participants.
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