The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation

NCT03640325 | Completed Results DMC

• 2 other identifiers: STUDY00001077 (SC-N126)R01CA225629
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cancer; Bone Marrow Neoplasms; Anxiety; Depression; Quality of Life; Adherence, Medication; Coping Skills; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score

  The Hospital Anxiety and Depression Scale -Depression sub scale assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for depression. Each is scored from 0-3, for a total range of 0-21 points. "Caseness" of depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.8 for depression. The depression sub-scale will be measured as a continuous variable. Higher scores indicate more symptoms.

  6-months

Secondary Outcomes (7)

• PedsQL Generic Core and Cancer-Related Quality of Life Score

  6-months

• Connor-Davidson Resilience Scale

  6-months

• Hope Scale Scores

  6-months

• Hospital Anxiety & Depression Scale Score - Anxiety Sub-score

  6-months

• Generalized Anxiety Disorder Screener (GAD7)

  6-months

Study Arms (3)

PRISM (Promoting Resilience in Stress Management)

EXPERIMENTAL

Resilience Skills Training

Behavioral: PRISM (Promoting Resilience in Stress Management)

Usual Care

NO INTERVENTION

Usual psychosocial care (control arm, no intervention)

Caregivers

NO INTERVENTION

Caregivers of participants, no intervention

Interventions

PRISM (Promoting Resilience in Stress Management) BEHAVIORAL

Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

PRISM (Promoting Resilience in Stress Management)

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Children's Hospital Los Angeles: collaborator
• St. Jude Children's Research Hospital: collaborator
• University of Alabama at Birmingham: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (5)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, 02215, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Seattle Children's Hospital Cancer and Blood Disorders Center

Seattle, Washington, 98145, United States

Location

Related Publications (2)

• Taylor MR, Cole SW, Bradford MC, Zhou C, Fladeboe KM, Knight JM, Baker KS, Yi-Frazier JP, Rosenberg AR. Resilience Intervention Improves Stress-Related Gene Expression in Adolescent and Young Adult HCT Recipients. Transplant Cell Ther. 2024 Dec;30(12):1209.e1-1209.e7. doi: 10.1016/j.jtct.2024.09.014. Epub 2024 Sep 19.

  PMID: 39303988 DERIVED

• Fladeboe KM, Scott S, Comiskey L, Zhou C, Yi-Frazier JP, Rosenberg AR. The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. BMC Palliat Care. 2022 May 19;21(1):82. doi: 10.1186/s12904-022-00966-9.

  PMID: 35585525 DERIVED

MeSH Terms

Conditions

Neoplasms; Bone Marrow Neoplasms; Anxiety Disorders; Depression; Medication Adherence; Adolescent Behavior

Condition Hierarchy (Ancestors)

Hematologic Neoplasms; Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Dr Abby Rosenberg
• Organization: Dana-Farber Cancer Institute

abbyr_rosenberg@dfci.harvard.edu

617.632.5286

Study Officials

• Abby R Rosenberg, MD, MS, MA

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 21, 2018
• Study Start: April 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)