- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242964
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
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:
- 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.
- 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaitlyn M Fladeboe, PhD
- Phone Number: 2068844140
- Email: katy.fladeboe@seattlechildrens.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
Standard psychosocial care
|
|
Experimental: PRISM-SN Intervention
Skill-based psychosocial program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
Time Frame: 12-weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: 12-weeks
|
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.
|
12-weeks
|
Snyder Hope Scale
Time Frame: 12-weeks
|
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.
|
12-weeks
|
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
Time Frame: 12-weeks
|
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.
|
12-weeks
|
Connor-Davidson Resilience Scale (CS-RISC)
Time Frame: 12-weeks
|
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.
|
12-weeks
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12-weeks
|
The Hospital Anxiety and Depression Scale (HADS) assesses mixed affective symptoms in patients with serious illness.
The scale includes 7 questions for anxiety and 7 for depression.
Each is scored from 0-3 for a total range of 0-21 for each subscale.
Clinically relevant symptoms are defined as scores of 8 or higher for both anxiety and depression.
|
12-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM)
Time Frame: 12-weeks
|
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.
|
12-weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kaitlyn M Fladeboe, PhD, Seattle Children's
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00004509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on Promoting Resilience in Stress Management - Social Needs (PRISM-SN)
-
Seattle Children's HospitalUniversity of Alabama at Birmingham; St. Jude Children's Research Hospital; Children...Active, not recruitingDepression | Quality of Life | Cancer | Anxiety | Adherence, Medication | Coping Skills | Bone Marrow Neoplasms | Adolescent BehaviorUnited States
-
Seattle Children's HospitalCompletedSarcoma | Lymphoma | Cancer | Acute Lymphoblastic Leukemia | Acute Myelogenous Leukemia | Brain Tumors | Germ Cell TumorUnited States
-
University of WashingtonNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingCommunication | Chronic Illness | Discrimination, Racial | Bias, RacialUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); Baylor College of Medicine; Seattle Children... and other collaboratorsActive, not recruitingDepression | Quality of Life | Cancer | Anxiety | Communication | Coping Skills | HopeUnited States
-
Seattle Children's HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting
-
Seattle Children's HospitalCompleted
-
University of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCongenital Heart DiseaseUnited States
-
Children's Hospital of PhiladelphiaNational Institute of Neurological Disorders and Stroke (NINDS); North American...RecruitingMitochondrial Diseases | Mitochondrial Myopathies | MELAS | Mitochondrial Encephalomyopathies | MERRFUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)RecruitingStress | AnxietyUnited States
-
University of Alabama at BirminghamRecruiting