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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    90
  • sponsor
    Seattle Children's Hospital
Updated on 28 March 2021
cancer
cell transplantation
primary cancer
cancer care

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 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.

Details
Condition Bone marrow disorder, Hematologic Malignancy, Cancer, Endogenous depression, Depression, Adolescent Behavior, Coping Behavior, Noncompliance with medication regimen, Quality of life, Bone Marrow Neoplasms, ANXIETY NEUROSIS, Anxiety, Depression (Major/Severe), Anxiety Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Cancer/Tumors, Ewing's Family Tumors, Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Cancer (Pediatric), Anxiety Symptoms, Anxiety Disorders, Blood Cancer, Neoplasms, Hematologic Cancer, Hematologic Neoplasms, depressive disorder, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, anxiety disorder, depressed mood, miserable, quality-of-life, depressive disorders, anxious
Treatment PRISM (Promoting Resilience in Stress Management)
Clinical Study IdentifierNCT03640325
SponsorSeattle Children's Hospital
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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