Clinical trial NCT03640325: The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Bone Marrow Neoplasms
Anxiety
Depression
Quality of Life
Adherence, Medication
Coping Skills
Adolescent Behavior
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: St. Jude Children's Research Hospital
name: University of Alabama at Birmingham
name: National Cancer Institute (NCI)
First posted: 2018-08-21
Enrollment: 143
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria for adolescent/young adult (AYA) patient:

* 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 for AYA patient:

* 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):

Inclusion criteria:

* 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

Primary outcomes:
measure: Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score
timeFrame: 6-months
Secondary outcomes:
measure: PedsQL Generic Core and Cancer-Related Quality of Life Score
timeFrame: 6-months
measure: Connor-Davidson Resilience Scale
timeFrame: 6-months
measure: Hope Scale Scores
timeFrame: 6-months
measure: Hospital Anxiety & Depression Scale Score - Anxiety Sub-score
timeFrame: 6-months
measure: Generalized Anxiety Disorder Screener (GAD7)
timeFrame: 6-months
measure: Patient Health Questionnaire-8
timeFrame: 6-months
measure: Medical Outcomes Study Rand 36-item Health Survey
timeFrame: 6-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center
state: Massachusetts
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Seattle
country: United States
facility: Seattle Children's Hospital Cancer and Blood Disorders Center
state: Washington
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Abby R Rosenberg, MD, MS, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fladeboe KM, Scott S, Comiskey L, Zhou C, Yi-Frazier JP, Rosenberg AR. The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. BMC Palliat Care. 2022 May 19;21(1):82. doi: 10.1186/s12904-022-00966-9.