The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorSeattle Children's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Aged <12 or >25 years
Diagnosed with recurrent malignancy
Diagnosed with new malignancy >6 months
Not receiving chemotherapy and/or radiation
Trial design
Design model
Parallel
Treatments tested in this trial
Promoting Resilience in Stress Management - Social Needs (PRISM-SN)
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PRISM-SN InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
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.
Time frame
12-weeksSecondary outcomes
1
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief tool designed to measure support from family, friends, and a significant other. It includes 12 items with 4 per subscale. Items are rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). It has been validated in both adolescents and adults. Mean scale scores ranging from 1-2.9 can be considered low support; 3-5 considered moderate support; and 5.1-7 considered high support.
Time frame
12-weeks2
Snyder Hope Scale
The Snyder Hope Scale contains 8 hope items plus 4 filler questions, and measures the overall perception that one's goals can be met. Each item is scored on an 8-point Likert scale; higher scores imply greater levels of hopeful thought patterns.
Time frame
12-weeks3
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
The Pediatric Profile-25 (v2.0) includes 25 items assessing health status across 7 domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference, and pain intensity. For this study, we will also include the 4-items pediatric family relationships short-form subscale (v1.0). All items are scored on a 5-point Likert scale except for a single pain intensity item scored on a 10-point scale; higher scores indicate more of each domain. Total raw scores are converted to standardized T-scores with a population mean of 50 and a standard deviation of 10.
Time frame
12-weeks4
Connor-Davidson Resilience Scale (CS-RISC)
The Connor-Davidson Resilience Scale (CS-RISC) is a reliable and widely used instrument assessing self-perceived resilience. Scores range from 0-40, with higher scores indicating higher self-perceived resilience.
Time frame
12-weeksOther outcomes
1
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) assess perceived intervention acceptability. It includes 4-items such as "\[program\] meets my approval," scored 1-5, with higher scores reflecting more acceptability. Scores are averaged across items. This measure will be completed by experimental arm participants only.
Time frame
12-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
University of Pittsburgh Medical Center
Collaborator
Source ClinicalTrials.gov