Psychosocial Intervention for Blood Cancer Caregivers

(BMT-CARE Trial)

Recruiting at 2 trial locations

Overseen By Jamie Jacobs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Benign hematologic condition, untreated psychiatric, others

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

Compensation: Varies

Number of Visits: 66

Duration: 8-10 weeks

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a program called BMT-CARE can improve the quality of life for caregivers and patients undergoing blood stem cell transplants. BMT-CARE includes six sessions that teach caregivers skills to better support their loved ones, compared to the usual care. The trial aims to identify factors that make the program easy or difficult to use. It is designed for adults who are close to someone receiving a blood stem cell transplant for cancer, see them at least twice a week, and understand English or Spanish. As an unphased trial, participants contribute to valuable research that may enhance caregiver support and patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the BMT-CARE intervention is safe for caregivers?

Research has shown that the BMT-CARE program is generally safe for caregivers. In an earlier study, caregivers using the BMT-CARE app experienced a better quality of life and fewer symptoms of depression and PTSD (post-traumatic stress disorder). No major reports of harmful effects or negative side effects emerged from using the app. This suggests that BMT-CARE is well-tolerated and does not pose significant safety concerns for caregivers in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BMT-CARE because it offers a fresh approach for supporting blood cancer caregivers. Unlike standard care, which involves meeting a social worker, BMT-CARE incorporates cognitive behavioral therapy (CBT) to enhance caregivers' knowledge and skills. This program is unique because it integrates education about hematopoietic cell transplantation (HCT) with CBT strategies, which could empower caregivers to manage stress and improve their well-being more effectively. This innovative combination has the potential to provide more comprehensive support compared to standard options.

What evidence suggests that BMT-CARE is effective for improving the quality of life in blood cancer caregivers?

Research has shown that BMT-CARE, which participants in this trial may receive, benefits caregivers of blood cancer patients. Caregivers using BMT-CARE report improved quality of life and reduced depression and anxiety. They also find caregiving tasks easier to manage and feel more confident in their role. At 60 days post-transplant, caregivers using BMT-CARE achieved better outcomes compared to those receiving only usual care. This suggests that BMT-CARE could significantly enhance caregivers' lives. ^{1 3 6 7 8}

Who Is on the Research Team?

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Jamie M Jacobs, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for caregivers of patients undergoing bone marrow transplants. Caregivers must be adults who are responsible for the patient's care during the transplant process.

Inclusion Criteria

I am caring for someone undergoing a stem cell transplant for cancer.

Ability to respond to questions in English, Spanish, or with minimal assistance from an interpreter

Ability to read and respond to survey questions in English, Spanish or with minimal assistance from an interpreter

Exclusion Criteria

Caregivers with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent

I am a caregiver for someone having a stem cell transplant for a non-cancerous blood condition or as an outpatient.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the BMT-CARE intervention, a 6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention, from enrollment up to 60 days post-HCT

8-10 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for quality of life, healthcare utilization, and mental health resource utilization up to 180 days post-HCT

120 days

Questionnaires at baseline, and days 60, 90, and 180 post-HCT

Open-label extension (optional)

Participants may continue to receive usual care and psychosocial support as needed

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• BMT-CARE

Trial Overview The study compares a psychological support program called BMT-CARE with usual care to see if it helps improve life quality for caregivers. It also looks at what makes BMT-CARE easy or hard to adopt.

How Is the Trial Designed?

Group I: BMT-CARE Experimental Treatment 1 Intervention

Participants randomized to BMT-CARE plus usual care will complete the following: * Questionnaires at baseline, and days 60, 90 and 180 post HCT. * Receive the BMT-CARE intervention from enrollment up to 60 days post-HCT. BMT-CARE is a -6-session caregiver-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that integrates HCT-related education with CBT strategies to enhance caregiver knowledge and skills. * Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to usual care will complete the following * Questionnaires at baseline, and days 60, 90 and 180 post HCT. * Receive usual care as per HCT practice which entails meeting a transplant social worker prior to HCT and as needed for extra visits.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A pilot class designed to help patients and caregivers manage psychosocial challenges during hematopoietic cell transplantation was well-received, with 80% of patients and 65% of caregivers feeling it met their expectations.

The class, which included valuable information on finances and emotional support, was recommended by 73% of patients and 93% of caregivers, highlighting its potential importance in standard pre-transplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Program Evaluation of a Class Addressing Psychosocial Topics in Preparation for Hematopoietic Cell Transplantation: a Brief Report. Macleod, F., Pink, J., Beattie, S., et al.[2023]

One-fourth of patients undergoing allogeneic bone marrow transplantation (BMT) showed significant psychosocial maladjustment before the procedure, indicating that they faced greater adjustment challenges than those who had already survived BMT.

Caregivers of BMT patients reported more difficulties in family relationships and similar levels of distress compared to the patients themselves, highlighting the need for support for both patients and caregivers during the pre-BMT process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial adjustment of patients and caregivers prior to allogeneic bone marrow transplantation. Siston, AK., List, MA., Daugherty, CK., et al.[2015]

Caregivers of patients undergoing allogeneic hematopoietic cell transplantation (HCT) experience a greater number of negative psychological impacts, with anxiety and worry being the most frequently reported issues, highlighting the emotional toll of this treatment on significant others.

Despite the challenges, caregivers also reported some positive psychological states and adaptive coping strategies, suggesting that interventions should focus on helping them manage distress and enhance their coping mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Impacts and Ways of Coping Reported by Spousal Caregivers of Hematopoietic Cell Transplant Recipients: A Qualitative Analysis. Langer, SL., Yi, JC., Chi, NC., et al.[2021]

In a study of 170 caregivers of patients undergoing hematopoietic stem cell transplantation, those who used approach-oriented coping strategies reported significantly lower levels of anxiety and depression, as well as better quality of life.

Conversely, caregivers who relied on avoidant coping strategies experienced higher anxiety and depression symptoms, along with a worse quality of life, highlighting the importance of promoting adaptive coping resources for these caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping in caregivers of patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. Amonoo, HL., Johnson, PC., Nelson, AM., et al.[2023]

Bone Marrow and Peripheral Blood Stem Cell Transplantation (BMT/PBSCT) is crucial for curing many patients with blood diseases, but it also brings significant stress to patients and their families due to high mortality risks and treatment side effects.

Effective psychosocial support is essential during and after BMT/PBSCT, and should be systematically integrated into both inpatient and outpatient care to address the psychological and social challenges faced by patients and their donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological problems and treatment possibilities in intensive care medicine exemplified by bone marrow transplantation]. Schulz-Kindermann, F., Weis, J., Ramm, G., et al.[2015]

Bone marrow transplantation (BMT) is a highly invasive treatment for cancer that requires significant psychosocial support due to the intense physical and emotional challenges faced by patients.

The paper highlights the importance of a dedicated psychosocial liaison service in BMT units, which addresses the unique needs of patients, their families, and medical staff, and suggests improvements for integrating psychosocial care into the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in psychosocial management of cancer patients undergoing bone marrow transplantation]. Weis, J., Köchlin, G.[2006]

The BMT-CARE intervention, a 6-session program for caregivers of hematopoietic stem cell transplantation recipients, significantly improved their quality of life and mood, with 100 caregivers participating in the study.

Improvements in coping skills and self-efficacy were found to mediate these positive effects, accounting for a substantial portion of the intervention's impact on quality of life and reductions in depression and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced coping and self-efficacy in caregivers of stem cell transplant recipients: Identifying mechanisms of a multimodal psychosocial intervention. Jacobs, JM., Nelson, AM., Traeger, L., et al.[2023]

A family-focused intervention for families undergoing bone marrow transplantation (BMT) showed positive effects on cohesion and emotional distress management, with 31 families participating in the intervention compared to 29 control families receiving usual care.

While caregivers reported the most distress, they benefited the least from the intervention, whereas BMT recipients and children experienced significant improvements, indicating a need for future research to enhance support specifically for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary efficacy of a brief family intervention to prevent declining quality of life secondary to parental bone marrow transplantation. Fife, BL., Von Ah, DM., Spath, ML., et al.[2018]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00713

BMT-CARE App: A Randomized Controlled Trial of ... The BMT-CARE App led to significantly improved QOL, caregiving burden, depression, and PTSD symptoms among HSCT caregivers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7103553/

Multimodal Psychosocial Intervention for Family Caregivers ... BMT-CARE led to a significant improvement in caregiver QOL, caregiving burden, anxiety and depression symptoms, as well as self-efficacy and ...

3. astctjournal.org astctjournal.org/article/S1083-8791(19)31097-3/fulltext

Multimodal Psychosocial Intervention for Caregivers of ... We assessed the preliminary efficacy of BMT-CARE for improving caregiver-reported outcomes at 60 days post-HCT using analysis of covariance adjusting for ...

4. curetoday.com curetoday.com/view/bmt-care-app-improves-quality-of-life-and-mental-health-for-caregivers

BMT-CARE App Improves Quality of Life and Mental Health ... At 60 days after transplant, caregivers who used the BMT-CARE App reported better quality of life compared to those receiving usual care, with ...

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

The Caregiver Paradigm in Hematopoietic Cell Transplant The requirement to have a caregiver has been shown to impact access to alloHCT. In a series of vignettes provided to clinicians, 69.3% of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979604/

a study protocol for the BMT-CARE app - PMC Participants complete questionnaires at baseline and days 10, 60 and 100 post-HSCT. The primary outcome is comparison of QOL at day 60 post-HSCT ...

7. ascopubs.org ascopubs.org/doi/pdfdirect/10.1200/JCO-25-00713

BMT-CARE App Effect of the BMT-CARE App on Caregiver-Reported Outcomes 60 Days After Hematopoietic Stem-Cell Transplantation: Results of. Analysis of ...

8. astctjournal.org astctjournal.org/article/S1083-8791(18)30327-6/pdf

Quality of Life of Caregivers of Hematopoietic Cell ... A B S T R A C T. Caregivers are critical to recipient recovery after hematopoietic cell transplant (HCT); however, little is known about.