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The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT03668223
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Children's Hospital Los Angeles
Baylor College of Medicine
Information provided by (Responsible Party):
Abby Rosenberg, Seattle Children's Hospital

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

Condition or disease Intervention/treatment Phase
Cancer Quality of Life Anxiety Depression Hope Coping Skills Communication Behavioral: Promoting Resilience in Stress Management (PRISM) Phase 3

Detailed Description:

Among patients with cancer and their families, early integration of palliative care may improve quality of life. This is particularly important for Adolescents and Young Adults (AYAs) because their distinct developmental challenges related to identity, relationships, and vocation may add to the burden of cancer.1-5 Among AYAs with advanced cancer, most understand that they may die and report that discussing end-of-life preferences, goals, and fears would be helpful; however, only 53% engage in such conversations.6-8 While national guidelines call for integrated palliative care in AYA oncology,9-11 developmentally targeted, evidence-based interventions designed to meet psychosocial and communication needs are lacking.

A potential barrier to improving the experiences of AYAs with advanced cancer may be their limited opportunities to develop "resilience resources" such as stress-management, goal-setting, positive reframing, and meaning-making skills.12 These resources may mitigate negative outcomes, facilitate engagement in goals of care discussions, and improve quality of life.13-15 Furthermore, promoting these resources among AYAs may give them the tools to more successfully navigate the challenges of the cancer experience.

Our research program is built on the central hypothesis that promoting resilience resources will improve psychosocial well-being. Over a series of studies, we developed a conceptual framework of resilience in pediatric cancer,12,16 affirmed associations between resilience resources and outcomes,17 and developed a novel resilience resources intervention (Promoting Resilience in Stress Management, PRISM).18 PRISM is a manualized, skills-based training program comprised of four 30-60 minute, in-person, one-on-one sessions plus a facilitated parent/caregiver/spouse/significant other family-meeting.

We recently completed a pilot Randomized Controlled Trial (RCT) to test the efficacy of PRISM among 100 AYAs, 6-months following their diagnosis of new (n=73) or recurrent (n=27) cancer (manuscript under review). Final results suggest PRISM is feasible, highly acceptable, and associated with increased patient-reported resilience as well as key clinically significant patient-centered outcomes such as quality of life and psychological distress. Subgroup analyses comparing patients with advanced cancer to those with new cancer suggested differentially stronger positive effects in the advanced cancer group, raising a hypothesis to be tested in dedicated trials. However, qualitative feedback from patients with advanced cancer suggested refinements targeting hopes, worries, and contextual meaning-making might strengthen PRISM's usefulness.

The overall objective of this project is to refine PRISM to meet the distinct needs of AYAs with Advanced Cancer. We will first adapt and iteratively test the existing PRISM based on established guidelines for intervention development.19 Then, we will conduct a multi-site randomized controlled trial to test the efficacy of a new PRISM for Advanced Cancer (PRISM-AC). Findings will inform the development of larger dissemination studies and standards of AYA end-of-life and palliative care. Ultimately, this research has the potential to reduce the burden of cancer in a highly vulnerable population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults With Advanced Cancer
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2023

Arm Intervention/treatment
Experimental: Promoting Resilience in Stress Management (PRISM)
Resilience Skills Training
Behavioral: Promoting Resilience in Stress Management (PRISM)
Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

No Intervention: Usual Care
Standard psychosocial care



Primary Outcome Measures :
  1. PedsQL Generic Core and Cancer-Specific Quality of Life scores [ Time Frame: 3-months ]
    Health-Related Quality of Life: The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of AYAs with cancer. Items are rated on a 5-point Likert scale and total scores transformed to a 0-100 scale with higher scores representing better HRQOL.


Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: 3-months ]
    The HADS assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for anxiety and 7 for depression. Each is scored from 0-3, for a total range of 0-21 points per subscale. "Caseness" of anxiety and depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.9 for anxiety and 0.8/0.8 for depression.

  2. Memorial Symptom Assessment Scale score [ Time Frame: 3-months ]
    Symptom Burden: The MSAS measures the presence, severity, frequency, and extent of bother from 32 symptoms Likert scales assess physical and psychological symptoms. Total- and sub-scores are calculated as an average and normalized to a scale of 0-100, with higher scores representing higher symptom burden.

  3. Hope scale score [ Time Frame: 3-months ]
    Hope: The Snyder "Hope" Scale measures "the overall perception that one's goals can be met." The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.

  4. Connor Davidson Resilience Scale [ Time Frame: 3-months ]
    Resilience: The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. Two items from the original 25-item CD-RISC were used to create a brief, 2-item scale (the CD-RISC2), namely items 1 ("Able to adapt to change") and 8 ("Tend to bounce back after illness or hardship"). Each item consists of a 5-point Likert scale (scored from zero to four). The 2-item scale has a total of 10 points, with higher scores reflecting greater perceived resilience.

  5. Palliative Care Engagement [ Time Frame: 3-months. ]
    Data will be abstracted from the medical record to track Adolescent involvement in shared decision-making and goals of care, including number/frequency of document medical decisions, completion of advance care planning documents, and palliative care resource utilization

  6. Parent Anxiety (Generalized Anxiety Disorder, GAD-7, scores) [ Time Frame: 3-months ]
    This 7-item survey is commonly used to identify cases of generalized anxiety disorder and to assess symptom severity. GAD-7 score range from 0 to 21, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe anxiety symptoms levels, respectively.

  7. Parent Depression (Patient Health Questionnaire, PHQ-8, scores) [ Time Frame: 3-months ]
    This 8-item survey is scored on a 4-point Likert scale and the sum (0- 27) indicates the degree of depression, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe depression.

  8. Parent Health-Related Quality of Life (SF-36 scores) [ Time Frame: 3-months ]
    The SF-36 incorporates 8 concepts: physical functioning, body pain, limitations due to physical health problems, role limitations due to personal or emotional problems as well as emotional well-being and social functioning, energy, fatigue and general health perceptions. Scores will be summed and normalized to a 100 point (0-100) scale, with higher scores indicating higher quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Receiving cancer care at Seattle Children's Hospital, Children's Hospital Los Angeles, or Texas Children's Hospital
  • Able to speak English
  • Able to read English or Spanish
  • Cognitively able to participate in interviews

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668223


Contacts
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Contact: Abby R Rosenberg, MD, MS, MA 206-987-2106 abby.rosenberg@seattlechildrens.org
Contact: Alison O'Daffer, BA Alison.O'Daffer@seattlechildrens.org

Locations
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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 900278
Contact: David Freyer, MD       DFreyer@chla.usc.edu   
Principal Investigator: David Freyer, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Scott Maurer, MD       scott.maurer@chp.edu   
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Tammy Kang, MD, MSCE       tikang@texaschildrens.org   
Principal Investigator: Tammy Kang, MD         
Sub-Investigator: Stacey Berg, MD         
United States, Washington
Seattle Children's Hospital Cancer and Blood Disorders Center Recruiting
Seattle, Washington, United States, 98145
Contact: Abby R Rosenberg, MD, MS, MA    206-987-2106    abby.rosenberg@seattlechildrens.org   
Contact: Samantha Scott, BA       samantha.scott@seattlechildrens.org   
Principal Investigator: Abby R Rosenberg, MD, MS, MA         
Sponsors and Collaborators
Seattle Children's Hospital
Children's Hospital Los Angeles
Baylor College of Medicine
Investigators
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Principal Investigator: Abby R Rosenberg, MD, MS, MA Seattle Children's Hospital
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Responsible Party: Abby Rosenberg, Associate Professor, Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03668223    
Other Study ID Numbers: SC-N128
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All IPD will be deidentified and stored securely on local servers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No