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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
Sponsor:
Collaborators:
Children's Hospital Los Angeles
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
Abby Rosenberg, Seattle Children's Hospital

Brief Summary:
Multisite Randomized Controlled Trial (RCT) testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving hematopoietic cell transplantation for hematology malignancy.

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

Detailed Description:
The experience of hematopoietic cell transplantation (HCT) for hematologic malignancy among Adolescents and Young Adults (AYAs) is particularly difficult because age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Compared to other age-groups, AYAs have poorer psychosocial outcomes including increased anxiety and depression and poorer adherence to oral immunosuppressive medications. These outcomes may, in turn, predispose AYAs to disease-related morbidity and mortality such as graft-versus-host disease (GVHD) and/or cancer-relapse. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity. We have previously developed the "Promoting Resilience in Stress Management" (PRISM) intervention for AYAs with serious illness. This manualized, brief intervention is delivered in 4, 30-60 minute, one-on-one sessions, followed by a Parent/ Caregiver/ Spouse/ significant other inclusive meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient well-being in other populations, and preliminary findings from a recently closed phase II randomized controlled trial among AYAs with newly diagnosed cancer suggest PRISM is associated with improved health-related quality of life. This study will build on our prior experience and fill a critical knowledge gap regarding PRISM's impact among AYAs receiving HCT. Thus, we will conduct a multi-site randomized controlled trial among N=70 AYAs (n=35 PRISM and n=35 usual care; ages 12-24 years), with the primary trial outcome of patient-reported symptoms of anxiety and depression. Secondary outcomes will include the cost-effectiveness of the intervention in this population and the impact of the intervention on parent well-being. Exploratory outcomes will assess patient adherence to oral chemotherapy. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms and demonstrate better adherence, while their parents report improved quality of life and psychological distress. We also anticipate the intervention will be cost-effective. In sum, this study offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based psychosocial interventions and standards of care for AYAs with hematologic malignancies. Ultimately, this research has the potential to reduce the burden of cancer in these vulnerable populations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. 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.

  2. 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



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:

  • Patient aged 12-24 years
  • Receiving allogeneic hematopoietic cell transplantation (HCT) at Seattle Cancer Care Alliance or Children's Hospital Los Angeles
  • Within 4 weeks of HCT "day zero"
  • Able to speak English
  • Able to read English or Spanish
  • Cognitively able to participate in interviews

Exclusion Criteria:

  • Patient refusal
  • Cognitively or physically unable to participate in interviews
  • Unable to speak English
  • Unable to read English or Spanish
  • Not receiving allogeneic HCT for treatment of malignancy

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): NCT03640325


Contacts
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Contact: Abby R Rosenberg, MD, MS, MA 206-987-2106 abby.rosenberg@seattlechildrens.org
Contact: Samantha Scott samantha.scott@seattlechildrens.org

Locations
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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    abby.rosenberg@seattlechildrens.org   
Contact: Samantha Scott       samantha.scott@seattlechildrens.org   
Principal Investigator: Abby R Rosenberg, MD, MS, MA         
Sponsors and Collaborators
Seattle Children's Hospital
Children's Hospital Los Angeles
St. Jude Children's Research Hospital
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: NCT03640325     History of Changes
Other Study ID Numbers: STUDY00001077 (SC-N126)
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All IPD will be protected and maintained by the study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Bone Marrow Diseases
Hematologic Diseases