The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT03640325|
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Bone Marrow Neoplasms Anxiety Depression Quality of Life Adherence, Medication Coping Skills Adolescent Behavior||Behavioral: PRISM (Promoting Resilience in Stress Management)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 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 Receiving Hematopoietic Cell Transplantation|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: PRISM (Promoting Resilience in Stress Management)
Resilience Skills Training
Behavioral: PRISM (Promoting Resilience in Stress Management)
Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
No Intervention: Usual Care
Usual psychosocial care (control arm, no intervention)
- Hospital Anxiety & Depression Scale Score [ Time Frame: 6-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: 6-months ]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.
- PedsQL Generic Core and Cancer-Related Quality of Life Score [ Time Frame: 6-months ]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. Internal consistency ranges from 0.75 to 0.92.
- Connor-Davidson Resilience Scale [ Time Frame: 6-months ]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.
- Cost-Effectiveness of PRISM intervention [ Time Frame: 6-months ]The main cost-analyses will determine the total, per-patient, 6-month costs of PRISM versus usual care. Using Quality-adjusted life years (QALYs) we will then estimate the incremental cost-effectiveness ratio (ICER). QALYs will be calculated with Health Utilities Index scores. The HUI consists of 15 total queries to assess 2 systems; scoring is based on standard gamble utilities, with scores from 0 (health-state preference equivalent to death) to 1 (perfect health). Costs will be measured with a study-specific cost-of-care checklist adapted from consensus guidelines to track direct and indirect patient costs.
- Hope Scale Scores [ Time Frame: 6-months ]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.
- Parent Generalized Anxiety Disorder (GAD-7 scores) [ Time Frame: 6-months ]Parent Anxiety: 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 (PHQ-8 scores) [ Time Frame: 6-months ]Parent Depression: 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 quality of life (SF-36 scores) [ Time Frame: 6-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.
- Impact of PRISM on oral adherence to GVHD medications [ Time Frame: 6-months ]Exploratory aim: This study will use the medication electronic monitoring system (MEMS) monitoring device to evaluate real-time medication adherence. Participants will store prescriptions for their primary GVHD prophylaxis in study-dispensed MEMS bottles and caps. Digital data with each cap-opening will be tracked and matched to prescription records to evaluate adherence, with a threshold of >90% indicating adherent versus non-adherent behavior.
- Impact of PRISM on heart-rate variability [ Time Frame: 6-months ]Exploratory aim: A subset of patients will participate in an optional companion study to evaluate the impact of PRISM on Heart Rate Variability as a biomarker of stress
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): NCT03640325
|Contact: Abby R Rosenberg, MD, MS, MAemail@example.com|
|Contact: Samantha Scottfirstname.lastname@example.org|
|United States, California|
|Children's Hospital of Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Hisham Abdel-Azim, MD HAbdelAzim@chla.usc.edu|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Not yet recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Deena Levine, MD 901-595-4446 Deena.Levine@STJUDE.ORG|
|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 email@example.com|
|Contact: Samantha Scott firstname.lastname@example.org|
|Principal Investigator: Abby R Rosenberg, MD, MS, MA|
|Principal Investigator:||Abby R Rosenberg, MD, MS, MA||Seattle Children's Hospital|