N/A
N=143
The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation
Cancer · Bone Marrow Neoplasms · Anxiety · Depression · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT03640325 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score — 4.55; 4.03 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRISM (Promoting Resilience in Stress Management) (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score |
4.55; 4.03 | — |
| SECONDARY PedsQL Generic Core and Cancer-Related Quality of Life Score |
73.48; 77.14 | — |
| SECONDARY Connor-Davidson Resilience Scale |
27.65; 29.64 | — |
| SECONDARY Hope Scale Scores |
47.21; 49.37 | — |
| SECONDARY Hospital Anxiety & Depression Scale Score - Anxiety Sub-score |
5.86; 5.13 | — |
| SECONDARY Generalized Anxiety Disorder Screener (GAD7) |
5.3 | — |
| SECONDARY Patient Health Questionnaire-8 |
4.5 | — |
| SECONDARY Medical Outcomes Study Rand 36-item Health Survey |
72.0 | — |
Summary
Multisite Randomized Controlled Trial (RCT) testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving hematopoietic cell transplantation for hematology malignancy.
Eligibility Criteria
Inclusion Criteria for adolescent/young adult (AYA) patient:
- Patient aged 12-24 years
- Receiving hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition syndrome
- Within 4 weeks of HCT "day zero"
- Able to speak English
- Able to read English or Spanish
- Cognitively able to participate in interviews
Exclusion Criteria for AYA patient:
- Patient refusal
- Cognitively or physically unable to participate in interviews
- Unable to speak English
- Unable to read English or Spanish
For enrolled caregivers of AYA patient (no age limit):
Inclusion criteria
- AYA Child of caregiver agreed to participate
- One caregiver per patient-caregiver dyad
- Parent/guardian cognitively and physically able to participate
- Parent/guardian is able to speak/read English or Spanish
Data sourced from ClinicalTrials.gov (NCT03640325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.