NCT03668223

Brief Summary

Multi-Site Randomized Controlled Trial testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults with Advanced Cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 24, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

August 15, 2018

Results QC Date

September 12, 2024

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pediatric Quality of Life Cancer Module

    Pediatric Quality of Life (PedsQL) Cancer Module -This scale was designed to assess pediatric cancer-specific health related quality of life. This is a 27 item scale, with each item rated on a 5-point Likert scale where 0=never and 4=almost always. Higher scores represent better health-related quality of life. Scale range is 0-100.

    3-months

Secondary Outcomes (3)

  • Hospital Anxiety and Depression Scale (HADS) Total Score

    3-months

  • Snyder Hope Scale

    3-months

  • Connor Davidson Resilience Scale

    3-months

Study Arms (2)

Promoting Resilience in Stress Management (PRISM)

EXPERIMENTAL

Resilience Skills Training

Behavioral: Promoting Resilience in Stress Management (PRISM)

Usual Care

NO INTERVENTION

Standard psychosocial care

Interventions

Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Promoting Resilience in Stress Management (PRISM)

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-24 years
  • Diagnosed with advanced cancer: progressive, recurrent, refractory disease or any diagnosis with estimated overall survival \<50% at least 2 weeks prior to enrollment
  • Able to speak English
  • Able to read English or Spanish
  • Cognitively able to participate in interviews

You may not qualify if:

  • Patient Refusal
  • Parent Refusal (if patient \<18 years-old)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's Hospital Los Angeles

Los Angeles, California, 900278, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98145, United States

Location

Related Publications (4)

  • Rosenbaum ARP, Ream M, Fladeboe KM, Lau N, Yi-Frazier JP, Rosenberg AR. Examining Sociodemographic Differences in Response to Resilience Coaching for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation-A Post Hoc Analysis of the PRISM Intervention. Pediatr Blood Cancer. 2025 Nov;72(11):e31998. doi: 10.1002/pbc.31998. Epub 2025 Aug 31.

  • Rosenberg AR, Fladeboe KM, Zhou C, Bradford MC, Kang T, Maurer S, Freyer DR, Baker KS, Comiskey L, Junkins CC, Taylor MR, Yi-Frazier JP. Promoting Resilience in Stress Management: A Randomized Controlled Trial of a Novel Psychosocial Intervention for Adolescents and Young Adults With Advanced Cancer. JCO Oncol Pract. 2026 Feb;22(2):243-254. doi: 10.1200/OP-25-00161. Epub 2025 Apr 28.

  • O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for the promoting resilience in stress management (PRISM) intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. BMC Palliat Care. 2023 May 16;22(1):60. doi: 10.1186/s12904-023-01179-4.

  • O'Daffer A, Comiskey L, Scott SR, Zhou C, Bradford MC, Yi-Frazier JP, Rosenberg AR. Protocol for The Promoting Resilience in Stress Management (PRISM) Intervention: a multi-site randomized controlled trial for adolescents and young adults with advanced cancer. Res Sq [Preprint]. 2023 Apr 7:rs.3.rs-2748874. doi: 10.21203/rs.3.rs-2748874/v1.

MeSH Terms

Conditions

NeoplasmsAnxiety DisordersDepressionCommunication

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Abby Rosenberg
Organization
Dana Farber Cancer Institute

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
Principal Investigator

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 12, 2018

Study Start

April 15, 2019

Primary Completion

January 23, 2024

Study Completion

October 31, 2025

Last Updated

December 5, 2025

Results First Posted

October 24, 2024

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations