Psychoeducation for AlloHCT Caregivers

NCT07116018 | Recruiting

• 1 other identifier: 24-5539
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Caregivers; Stem Cell Transplant; Psychoeduction; Coping

Outcome Measures

Primary Outcomes (3)

• Feasibility of Intervention Measure (FIM)

  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.

  3 months

• Acceptability of Intervention Measure (AIM)

  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.

  3 months

• Intervention Appropriateness Measure (IAM)

  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.

  3 months

Secondary Outcomes (5)

• Perceived Stress

  Baseline, 1 month, 3 months

• Depression

  Baseline, 1 month, 3 months

• Caregiver Quality of Life

  Baseline, 1 month, 3 months

• Satisfaction with Life

  Baseline, 1 month, 3 months

• Anxiety

  Baseline, 1 month, 3 months

Study Arms (1)

Psychoeducational intervention

EXPERIMENTAL

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).

Behavioral: Psychoeducation

Interventions

Psychoeducation BEHAVIORAL

The intervention comprises 8 individual psychoeducational sessions over 12 weeks, as an adaptation of the Psychoeducation, Paced Respiration, and Relaxation (PEPRR) (Laudenslager et al., 2015). The adaptation in the current study involves delivery by a trained nurse and omission of the biofeedback component.

Psychoeducational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre, University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

• Laudenslager ML, Simoneau TL, Kilbourn K, Natvig C, Philips S, Spradley J, Benitez P, McSweeney P, Mikulich-Gilbertson SK. A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: effects on distress. Bone Marrow Transplant. 2015 Aug;50(8):1110-8. doi: 10.1038/bmt.2015.104. Epub 2015 May 11.

  PMID: 25961767 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Samantha Mayo, RN, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Mayo, RN, PhD

CONTACT

437-218-0860; samantha.mayo@uhn.ca

Grace Kusi, RN, PhD candidate

CONTACT

grace.kusi@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: May 21, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)