The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation

Not Applicable

Completed

Conditions: Quality of Life
Bone Marrow Neoplasms
Depression
Adherence, Medication
Coping Skills
Cancer
Anxiety
Adolescent Behavior

Interventions: Behavioral: PRISM (Promoting Resilience in Stress Management)

Registration Number: NCT03640325

Lead Sponsor: 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.

Detailed Description: The experience of hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition 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 with the primary trial outcome of patient-reported symptoms of anxiety and depression. Secondary and exploratory outcomes will include the cost-effectiveness of the intervention in this population, the impact of the intervention on parent well-being, and patient adherence to oral graft-versus-host-disease medications. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms, while their parents report improved quality of life and psychological distress. We also anticipate the intervention will positively impact adherence and 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRISM (Promoting Resilience in Stress Management)	PRISM (Promoting Resilience in Stress Management)	Resilience Skills Training

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score	6-months	The Hospital Anxiety and Depression Scale -Depression sub scale assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for depression. Each is scored from 0-3, for a total range of 0-21 points. "Caseness" of depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.8 for depression. The depression sub-scale will be measured as a continuous variable. Higher scores indicate more symptoms.

Secondary Outcome Measures

Name	Time	Method
PedsQL Generic Core and Cancer-Related Quality of Life Score	6-months	The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of adolescents and young adults (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	6-months	The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). ranging from 0-40 with higher scores reflecting greater perceived resilience.
Hope Scale Scores	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.
Hospital Anxiety & Depression Scale Score - Anxiety Sub-score	6-months	The Hospital Anxiety and Depression Scale - Anxiety sub scale assesses mixed affective symptoms in patients with serious illness. It consists of 7 questions on a 3 point Likert scale for a total range of 0-21. Higher scores indicate higher anxiety.
Generalized Anxiety Disorder Screener (GAD7)	6-months	7-item survey used to assess anxiety symptoms. Scored from 0-21 with higher scores indicated higher anxiety.
Patient Health Questionnaire-8	6-months	8-item survey assessing depression severity. Each item scored on a 4-point Likert scale with a range of 0-27. Higher scores indicate higher depression.
Medical Outcomes Study Rand 36-item Health Survey	6-months	This is a measure of health-related quality of life. Scores range from 0-100 and higher scores indicate better health status

Trial Locations

Locations (5): University of Alabama, Birmingham
🇺🇸
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
🇺🇸
Los Angeles, California, United States
St. Jude Children's Research Hospital
🇺🇸
Memphis, Tennessee, United States
Dana-Farber/Harvard Cancer Center
🇺🇸
Boston, Massachusetts, United States
Seattle Children's Hospital Cancer and Blood Disorders Center
🇺🇸
Seattle, Washington, United States