The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation

Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03640325
• Other study ID #: STUDY00001077 (SC-N126)
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

Inclusion Criteria:

• Patient aged 12-24 years

• Receiving hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition syndrome

• 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PRISM (Promoting Resilience in Stress Management)
Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Dana-Farber/Harvard Cancer Center	Boston	Massachusetts
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Seattle Children's Hospital Cancer and Blood Disorders Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Children's Hospital Los Angeles, St. Jude Children's Research Hospital, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of PRISM on heart-rate variability	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	6-months
Primary	Hospital Anxiety & Depression Scale Score - Depression sub-score	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. The depression sub-scale will be measured as a continuous variable.	6-months
Secondary	Memorial Symptom Assessment Scale Score	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.	6-months
Secondary	PedsQL Generic Core and Cancer-Related Quality of Life Score	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.	6-months
Secondary	Connor-Davidson Resilience Scale	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.	6-months
Secondary	Hope Scale Scores	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-months
Secondary	Parent Generalized Anxiety Disorder (GAD-7 scores)	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.	6-months
Secondary	Parent Depression (PHQ-8 scores)	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.	6-months
Secondary	Parent quality of life (SF-36 scores)	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.	6-months
Secondary	Hospital Anxiety and Depression Scale - Anxiety sub-score	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. The anxiety sub-scale will be measured as a continuous variable.	6-months