Psychoeducation for AlloHCT Caregivers

Not Applicable

Recruiting

• Conditions: Cancer; Coping; Caregivers; Stem Cell Transplant; Psychoeduction

• Registration Number: NCT07116018
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-21
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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.

Exclusion Criteria

• Less than 18 years of age
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure (FIM)	3 months	The Feasibility of Intervention Measure (FIM) revised to evaluated the psychoeducation program comprises 4-items regarding the respondent's perceptions of the feasibility of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater feasibility of the intervention.
Intervention Appropriateness Measure (IAM)	3 months	The Intervention Appropriate Measure (IAM) revised to evaluated the psychoeducation program comprises 4-items regarding the respondent's perceptions of the appropriateness of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater appropriateness of the intervention.
Acceptability of Intervention Measure (AIM)	3 months	The Acceptability of Intervention Measure (AIM) revised to evaluated the psychoeducation program comprises 4-items regarding the respondent's perceptions of the acceptability of the intervention. Responses range from 1 (completely disagree) to 5 (completely agree). Scale value is computed by averaging responses and ranges from 1-5. Higher values indicate greater acceptability of the intervention.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress	Baseline, 1 month, 3 months	Perceived Stress Scale (PSS)
Depression	Baseline, 1 month, 3 months	Centre for Epidemiological Studies- Depression (CES-D) scale
Caregiver Quality of Life	Baseline, 1 month, 3 months	Caregiver Quality of Life Index- Cancer Scale
Satisfaction with Life	Baseline, 1 month, 3 months	Satisfaction with Life Scale
Anxiety	Baseline, 1 month, 3 months	State-Trait Anxiety Inventory (STAI)

Trial Locations

Locations (1)

Princess Margaret Cancer Centre, University Health Network; 🇨🇦 Toronto, Ontario, Canada