The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started May 2024
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2024
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
June 25, 2024
June 1, 2024
2.2 years
January 29, 2024
June 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
The Cancer Behavior Inventory - Social Relationship Coping Efficacy measure assesses one's confidence to engage in behaviors that maintain or enhance close social relationships in the context of illness. Ten items are rated 1-10; items are summed, with higher scores reflecting higher social relationship coping efficacy.
12-weeks
Secondary Outcomes (5)
Multidimensional Scale of Perceived Social Support (MSPSS)
12-weeks
Snyder Hope Scale
12-weeks
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
12-weeks
Connor-Davidson Resilience Scale (CS-RISC)
12-weeks
Hospital Anxiety and Depression Scale (HADS)
12-weeks
Other Outcomes (1)
Acceptability of Intervention Measure (AIM)
12-weeks
Study Arms (2)
PRISM-SN Intervention
EXPERIMENTALSkill-based psychosocial program
Usual Care
NO INTERVENTIONStandard psychosocial care
Interventions
The Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention is a brief, skill-based psychosocial program. Five core sessions are delivered one-on-one, 1-2 weeks apart, in-person or via videoconference. Sessions teach evidence-based behavioral skills for managing stress, setting goals, reframing negative thoughts, meaning-making, and connecting with others. Each session lasts \<60 minutes and is supported by paper-and-pencil or mobile app-based worksheet(s) for learning and practice. A final review session may be completed individually or with a family member, caregiver, or significant other.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seattle Children's
Seattle, Washington, 98105, United States
Related Publications (1)
Fladeboe KM, Fredman G, Maurer SH, Zhou C, Bradford MC, Yi-Frazier JP, Salsman JM, Baker KS, Mack MC, Taylor MR, Rosenberg AR. Feasibility and proof-of-concept of a combined resilience and social connection intervention for adolescents and young adults with cancer: a pilot randomized trial protocol. Pilot Feasibility Stud. 2026 Jan 29. doi: 10.1186/s40814-026-01775-0. Online ahead of print.
PMID: 41612517DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaitlyn M Fladeboe, PhD
Seattle Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2024
First Posted
February 5, 2024
Study Start
May 15, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared after publication of study findings; coded banked data will be available indefinitely.
- Access Criteria
- Written request to the PI.
De-identified participant data may be shared upon request. Investigators interested in conducting additional analyses must request data directly from the PI via written correspondence and obtain and provide verification of institutional review board approval.