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Behavioral Intervention

Psychosocial Intervention for Blood Cancer Caregivers (BMT-CARE Trial)

N/A

Waitlist Available

Led By Areej El-Jawahri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer

Adult patients (≥18 years) with a hematologic malignancy and planned admission for autologous or allogeneic HCT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 180 post hct

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a new therapy called BMT-CARE can help improve the quality of life for caregivers and patients undergoing hematopoietic cell transplant. They also want to understand what factors

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a psychosocial intervention, there may not be physical side effects like in drug trials. However, participants might experience emotional discomfort discussing personal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

I am an adult with blood cancer planning to undergo a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 180 post hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 180 post hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 180 post hct for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire

Secondary study objectives

Caregiver anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) Scale

Caregiver coping as measured by the Measure of Current Status-A (MOCS-A) questionnaire

Caregiver depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) Scale

+2 more

Other study objectives

Patient anxiety symptoms as measured by the Hospital Anxiety and Depression (HADS-Anxiety) scale

Patient depression symptoms as measured by the Hospital Anxiety and Depression (HADS-Depression) scale

Patient medication adherence as measured by the Medication Adherence Report Scale (MARS-5)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BMT-CAREExperimental Treatment1 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 CareActive Control1 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.

0 / 2Eligibility criteria met