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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||195 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
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
|Contact: Abby R Rosenberg, MD, MS, MAemail@example.com|
|Contact: Alison O'Daffer, BA||Alison.O'Daffer@seattlechildrens.org|
|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 firstname.lastname@example.org|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Tammy Kang, MD, MSCE email@example.com|
|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 firstname.lastname@example.org|
|Contact: Samantha Scott, BA email@example.com|
|Principal Investigator: Abby R Rosenberg, MD, MS, MA|
|Principal Investigator:||Abby R Rosenberg, MD, MS, MA||Seattle Children's Hospital|