Feasibility Testing of an Adapted Psychoeducational Intervention for Caregivers of Patients Undergoing Allogeneic Stem Cell Transplant for Hematological Malignancy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for hematological malignancies face significant challenges that can impact their well-being. This study aims to evaluate the feasibility and acceptability of an adapted psychoeducational intervention(PEI) designed to support these caregivers.

Methods: This study will recruit caregivers of alloHCT patients. Participants will be enrolled during pre-transplant clinic visits, typically 2-4 weeks before the scheduled transplant. The intervention consists of eight sessions over 12 weeks, delivered via Microsoft Teams by a nurse facilitator. In the adapted PEI, participants will learn stress management, coping strategies, energy management, goal-setting, communication skills, and support resource access through interactive exercises. Data Collection: Participants will complete questionnaires at three time points: pre-intervention, one month post-transplant, and three months post-transplant. The final assessment will include additional questions about feasibility, acceptability and the initial efficacy of the adapted PEI. Outcomes: The primary outcomes will be the feasibility and acceptability of the adapted psychoeducational intervention (PEI). Secondary outcomes will include initial efficacy of the adapted PEI on caregiver outcomes such as depression, anxiety, satisfaction with caregiving and quality of life. Significance: This research aims to assess the feasibility, acceptability and initial efficacy of implementing the adapted PEI for alloHCT caregivers. If found feasible and acceptable, this intervention could potentially improve caregivers' ability to manage caregiving stressors and pave the way for larger-scale randomized studies and implementation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must be caregiver for an adult patient diagnosed with hematological malignancy who is scheduled to receive allogeneic stem cell transplant.

• Are recruited and consented to participate in the caregiver study during the patient's pre-transplant screening phase for allogeneic stem cell transplant.

• Will provide care for the patient from the day of allogeneic stem cell transplant up to 100 days post- transplant.

• Are willing to begin the study intervention no earlier than 0-day post-transplant and not later than 2-weeks post-transplant.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre, University Health Network
RECRUITING
Toronto
Contact Information
Primary
Samantha Mayo, RN, PhD
samantha.mayo@uhn.ca
437-218-0860
Backup
Grace Kusi, RN, PhD candidate
grace.kusi@uhn.ca
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2026-03
Participants
Target number of participants: 22
Treatments
Experimental: Psychoeducational intervention
The intervention will be psychoeducational program, comprising a series of 8 individual sessions over a 12 week period. The intervention is a manualized, adapted version of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) intervention (Laudenslager et al. 2015).
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov