This trial studies how well the Promoting Resilience in Stress Management (PRISM) intervention works in reducing anxiety and depression in adolescents and young adults with cancer who are undergoing a donor stem cell transplant. The PRISM intervention may help adolescents and young adults with cancer improve skills such as stress-management and mindfulness, goal-setting, positive reframing, and meaning-making, thereby reducing patient-reported symptoms of anxiety and depression.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03640325.
PRIMARY OBJECTIVES:
I. Evaluate the effect of Promoting Resilience in Stress Management (PRISM) compared to usual care on symptoms of anxiety and depression.
SECONDARY OBJECTIVES:
I. Evaluate PRISM’s impact on other key patient-reported outcomes 6-months following enrollment.
II. Evaluate the cost-effectiveness of the PRISM intervention.
III. Evaluate the impact of PRISM on parent outcomes 6-months following enrollment.
IV. Describe individual and group 6-month trajectories for patient reported outcomes of usual care and PRISM participants.
EXPLORATORY OBJECTIVES:
I. Evaluate the effectiveness of PRISM compared to usual care in promoting adherence to oral GVHD prophylaxis.
II. Prospectively describe associations between PRISM, patient reported anxiety and depression, and stress biomarkers.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive 4 PRISM one-on-one, in person sessions over 30-50 minutes approximately 1-2 weeks apart and a 5th session with caregiver. Participants may also receive “booster” contacts weekly over 10-20 minutes until 6 months from enrollment.
ARM II: Participants receive usual care.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorAbby Rachel Rosenberg