Clinical trial NCT06242964: The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
Official title: The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Social Functioning
Psychosocial Functioning
Coping Skills
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
First posted: 2024-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.

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

Primary outcomes:
measure: Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
timeFrame: 12-weeks
Secondary outcomes:
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 12-weeks
measure: Snyder Hope Scale
timeFrame: 12-weeks
measure: Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
timeFrame: 12-weeks
measure: Connor-Davidson Resilience Scale (CS-RISC)
timeFrame: 12-weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12-weeks
Other outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 12-weeks
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Kaitlyn M Fladeboe, PhD
role: PRINCIPAL_INVESTIGATOR
References: