A Pilot RCT of the PRISM Intervention for AYAs With Cancer

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Brief Title

A Pilot RCT of the PRISM Intervention for AYAs With Cancer

Official Title

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

Brief Summary

      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
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Patient-Reported Resilience

Secondary Outcome

 Patient-Reported self-efficacy

Condition

Cancer

Intervention

Promoting Resilience In Stress Management (PRISM)

Study Arms / Comparison Groups

 PRISM
Description:  Promoting Resilience In Stress Management Intervention (skills-based intervention designed to teach stress-management, goal-setting, cognitive reframing, and meaning-making skills)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

100

Start Date

January 30, 2015

Completion Date

December 19, 2021

Primary Completion Date

September 19, 2017

Eligibility Criteria

        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).
      

Gender

All

Ages

13 Years - 25 Years

Accepts Healthy Volunteers

No

Contacts

Abby R Rosenberg, MD, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02340884

Organization ID

SC-N114


Responsible Party

Principal Investigator

Study Sponsor

Seattle Children's Hospital


Study Sponsor

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


Verification Date

October 2020