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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PRISM (Promoting Resilience in Stress Management)

Resilience Skills Training

Group Type EXPERIMENTAL

PRISM (Promoting Resilience in Stress Management)

Intervention Type BEHAVIORAL

Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Usual Care

Usual psychosocial care (control arm, no intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Caregivers

Caregivers of participants, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRISM (Promoting Resilience in Stress Management)

Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* AYA Child of caregiver agreed to participate
* One caregiver per patient-caregiver dyad
* Parent/guardian cognitively and physically able to participate
* Parent/guardian is able to speak/read English or Spanish

Exclusion Criteria

* Patient refusal
* Cognitively or physically unable to participate in interviews
* Unable to speak English
* Unable to read English or Spanish

For enrolled caregivers of AYA patient (no age limit):

Minimum Eligible Age

12 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No