Psychoeducation for Caregivers of Bone Marrow Transplant Patients

Overseen By Grace Kusi, RN, PhD candidate

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Under 18, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of patients undergoing bone marrow transplants by testing a new support program called psychoeducation. The program teaches stress management, coping skills, and other helpful strategies through online sessions. Caregivers will answer questions about their feelings before and after the program to assess its effectiveness and ease of use. Those caring for someone with blood cancer undergoing a bone marrow transplant might be suitable for this trial. As an unphased trial, participants contribute to valuable research that may enhance caregiver support strategies.

Do I need to stop my current medications to participate in the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a psychoeducational program for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that this psychoeducational intervention is safe for caregivers?

Research has shown that psychoeducation can safely and effectively support caregivers. In one study, a program called PsychoEducation, Paced Respiration, and Relaxation (PEPRR) reduced stress in caregivers. This is important because stress can impact both mental and physical health.

The program tested in this trial is based on the PEPRR program, which has been used before without reports of harmful effects. It is not a drug or medical treatment, so there are no physical side effects. Instead, it consists of sessions that teach skills like managing stress and improving communication.

Caregivers who participated in similar programs in the past reported feeling less stressed and more supported. Since the sessions occur over video calls, they are convenient and require no travel. Overall, psychoeducation for caregivers has been well-received and appears to be a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical support options for caregivers of bone marrow transplant patients, which might include informal counseling or support groups, this psychoeducational intervention offers a structured, personalized approach. It involves a series of eight individual sessions over 12 weeks, specifically designed to equip caregivers with coping strategies through a manualized program. Researchers are excited because this method not only provides emotional support but also teaches practical skills like paced respiration and relaxation, which could significantly enhance caregivers' ability to manage stress and improve their overall well-being.

What evidence suggests that this psychoeducational intervention is effective for caregivers of bone marrow transplant patients?

Research has shown that educational support benefits caregivers of patients receiving bone marrow transplants. This trial will evaluate a psychoeducational intervention specifically designed for caregivers, consisting of 8 individual sessions over 12 weeks. Studies have found that this type of support can reduce caregiving stress and improve mental health. For instance, one study discovered that educational support lowered stress and enhanced coping skills for caregivers of children undergoing similar treatments. This positive effect lasted for at least a month after the support ended. Overall, educational support helps caregivers manage stress better, improving their quality of life during challenging times. ^{3 6 7 8 9}

Who Is on the Research Team?

Samantha Mayo, RN, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for caregivers of patients undergoing bone marrow transplants (alloHCT) for blood cancers. Caregivers who can participate will be identified during pre-transplant clinic visits and must have access to Microsoft Teams for the sessions.

Inclusion Criteria

I am a caregiver for someone getting a stem cell transplant for blood cancer.

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

I will have a caregiver from the day of my stem cell transplant for up to 100 days.

Exclusion Criteria

Non-English speaking

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-Intervention

Participants complete baseline questionnaires and prepare for the intervention

2-4 weeks

1 visit (virtual)

Intervention

Participants undergo an adapted psychoeducational intervention consisting of eight sessions over 12 weeks

12 weeks

8 sessions (virtual)

Follow-up

Participants are monitored for feasibility, acceptability, and initial efficacy of the intervention

3 months

3 assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Psychoeducation

Trial Overview The study tests an adapted psychoeducational intervention (PEI) delivered in eight sessions over 12 weeks via Microsoft Teams. It aims to teach caregivers stress management, coping strategies, energy management, goal-setting, communication skills, and how to find support resources.

How Is the Trial Designed?

Group I: Psychoeducational intervention Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360561/

Protocol for a systematic review and planned meta-analysis This review aims to systematically evaluate existing psychological interventions for caregivers of HSCT patients and report on: 1) the ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208122001152

The Effect of Psychoeducation on Care Burden Applied to ... The psychoeducation reduced the care burden experienced by the mothers of the children who underwent Allo-BMT and this positive impact lasted for a month.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.6050

The effectiveness of psychoeducational interventions on ... Psychoeducation has been shown to be effective in enhancing caregiving-oriented outcomes. A systematic assessment of the overall effect of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07116018

NCT07116018 | Psychoeducation for AlloHCT Caregivers In the adapted PEI, participants will learn stress management, coping strategies, energy management, goal-setting, communication skills, and ...

5. astctjournal.org astctjournal.org/article/S2666-6367(25)01147-9/fulltext

Multicenter Study on Caregiver Experiences in Pediatric ... This multicenter, longitudinal qualitative study explored the evolving mental health experiences, stressors, and coping strategies of 49 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00833898

Stress Management Intervention for Caregivers of Patients ... PURPOSE: This randomized phase III trial is studying a stress management intervention for caregivers of patients undergoing bone marrow transplant. Detailed ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK608993

Using a Program to Lower Stress for Caregivers of Patients ... We have shown that our PsychoEducation, Paced Respiration, and Relaxation (PEPRR) intervention reduces caregiver psychological distress.

8. withpower.com withpower.com/trial/phase-neoplasms-4-2025-1f044

Psychoeducation for Caregivers of Bone Marrow ... This study aims to evaluate the feasibility and acceptability of an adapted psychoeducational intervention(PEI) designed to support these caregivers.Methods: ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725012655

The Caregiver Paradigm in Hematopoietic Cell Transplant Strikingly few studies have examined the impact of caregivers on patient outcomes. Spouses are often the de facto caregivers for most patients, ...