A Pilot RCT of the PRISM Intervention for AYAs With Cancer

April 8, 2024 updated by: Abby Rosenberg, Seattle Children's Hospital

A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults With Cancer

Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer

Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50).

Study Design: Pilot randomized controlled trial (RCT).

Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer.

Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months.

Secondary Outcomes:

  1. Patient-reported resilience at 2, 4, and 12 months
  2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months.
  3. Qualitative assessment of patient-reported goals at 6 and 12 months
  4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes

Study Duration: 3 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The experience of serious illness among adolescents and young adults (AYAs) is unique because they face distinctive developmental challenges, transitions, and choices related to education, employment, identity, relationships and family. Age-specific interventions are needed to promote positive resources and outcomes. Resilience, for example, is a construct describing an individual's capacity to maintain psychological and/or physical well-being in the face of stress, and is a good candidate to buffer the negative effects of stress. While few studies have described positive outcomes in AYA patients with chronic disease, and fewer still have suggested mechanisms to promote resilience, evidence suggests promoting "resilience-resources" (e.g., stress-management and goal setting skills, meaning-making and positive-reframing of negative experiences), as a means to manage stress may be valuable.

We have previously described models and factors of resilience among AYAs with cancer as well as parents of children with cancer, and demonstrated that self-perceptions of resilience are strongly associated with outcomes. Through iterative pilot testing, we have successfully developed a novel, patient-centered resilience-based intervention, the "Promoting Resilience in Stress Management" (PRISM) intervention.

The overall goal of the PRISM intervention is to improve AYA self-perceived resilience, thereby reducing AYA distress, improving quality of life, and minimizing risky health behaviors. The brief format involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th, optional, family-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as monthly "booster" sessions. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.

Enrolled patients will be between 13 and 25 years-old with at least a 2 week history of new or recurrent malignancy. They will be randomized to receive the PRISM intervention or standard psychosocial supportive care. Patients in both groups will be invited to complete quantitative surveys at the time of enrollment and then 2-, 4-, 6-, and 12-months later. Participants will be compensated for their time.

The primary outcome of the study is self-perceived resilience, as measured by the Connor-Davidson Resilience Score, at 6-months post-enrollment. Secondary outcomes will assess resilience scores at 4, 6, and 12 months, as well as self-efficacy, anxiety, depression, benefit-finding, quality of life, goal-setting skills, and health behaviors at 6 and 12 months.

The study is anticipated to accrue a total of 100 patients over 2 years.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 13-25 years

    1. Patient aged 13-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation.
    2. Patient aged 18-25 years: has signed informed consent for study participation.

  2. Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)

    1. New diagnosis of malignancy within 1-10 weeks of enrollment
    2. New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of enrollment
  3. Ability to speak and read English language
  4. Cognitively able to participate in interactive interviews

Exclusion Criteria:

  1. Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
  2. Cognitively or physically unable to participate in interactive interview
  3. Unable to speak and read English language
  4. Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRISM
Promoting Resilience In Stress Management Intervention (skills-based intervention designed to teach stress-management, goal-setting, cognitive reframing, and meaning-making skills)
Behavioral: Promoting Resilience In Stress Management (PRISM)
The brief format of the PRISM intervention involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th parent-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as weekly (text- or email based) check-ins from study staff and in-person "booster" sessions once monthly. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.
No Intervention: Control
Standard psychosocial supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient-Reported Resilience
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient-Reported self-efficacy
Time Frame: 6 months
6 months
Patient-Reported benefit-finding
Time Frame: 6 months
6 months
Patient-Reported goal-setting skills
Time Frame: 6 months
6 months
Patient-Reported quality of life
Time Frame: 6 months
6 months
Patient-Reported health behaviors
Time Frame: 6 months
6 months
Patient-reported anxiety & depression
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Patient-reported resilience
Time Frame: 4- and 6- months
4- and 6- months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Investigators

  • Principal Investigator: Abby R Rosenberg, MD, MS, Seattle Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2015

Primary Completion (Actual)

September 19, 2017

Study Completion (Actual)

December 19, 2021

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimated)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-N114

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.

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