A Pilot RCT of the PRISM Intervention for AYAs With Cancer
Condition: Cancer; Acute Lymphoblastic Leukemia; Lymphoma; Sarcoma; Acute Myelogenous Leukemia; Brain Tumors; Germ Cell Tumor
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid; Neoplasms, Germ Cell and Embryonal; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Promoting Resilience In Stress Management (PRISM)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research