Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adherence, Medication
  • Adolescent Behavior
  • Anxiety
  • Bone Marrow Neoplasms
  • Cancer
  • Coping Skills
  • Depression
  • Quality of Life
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 12 years and 24 years
Gender
Both males and females

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-group...

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.

Tracking Information

NCT #
NCT03640325
Collaborators
  • Children's Hospital Los Angeles
  • St. Jude Children's Research Hospital
Investigators
Principal Investigator: Abby R Rosenberg, MD, MS, MA Seattle Children's Hospital