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Behavioural Intervention

CARE for Cancer Caregivers

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

A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant

Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a psychological intervention can improve quality of life and mood for caregivers of stem cell transplant patients.

Who is the study for?

This trial is for adult caregivers (18+ years) of cancer patients undergoing stem cell transplant. Caregivers must be in close contact with the patient, speak English or use an interpreter, and attend a specific consent visit. Those with uncontrolled psychiatric conditions or diseases that prevent participation are excluded.

What is being tested?

The study is testing a psychological intervention called CARE against standard care given during stem cell transplants to see if it improves the quality of life and mood of caregivers.

What are the potential side effects?

Since this is a psychological intervention, there may not be physical side effects like with medication. However, participants might experience emotional discomfort or stress when discussing personal topics.

Eligibility Criteria

Inclusion Criteria

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

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I have a primary caregiver who sees me at least twice a week.

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I am an adult caregiver for a patient getting a stem cell transplant and attended the consent visit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of the intervention (feasibility description below)

Secondary study objectives

Compare Caregiver QOL (CarGOQOL) between the study arms

Compare caregiver mood (HADS) between the study arms

Compare caregiver self-efficacy (CASE-t) between the study arms

+2 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: CARE interventionExperimental Treatment1 Intervention

* Six psychological intervention sessions in-person or via video conferencing conducted by a trained psychologist * The CARE intervention contain 3 component * a psychoeducational component to address preparednessmanage expectations, and develop caregiving skills * a psychosocial component focusing on coping strategies, mindfulness, and facilitating acceptance while living with uncertainty * a self-care component to promote caregiver health and well-being

Group II: Standard transplant careActive Control2 Interventions

* Standard Transplant Care * Social work consults to help caregivers only upon request

0 / 2Eligibility criteria met