Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

Study Overview
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Brief Summary
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This research study is evaluating the impact of a psychological intervention on the quality of life and mood of caregivers of patients undergoing stem cell transplant.

Detailed Description
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The purpose of this study is to find out whether a psychological intervention can make the experience of being a caregiver more manageable by improving the participant's quality of life, mood, and caregiving burden during the participant's loved one's transplant process. The psychological intervention will entail six visits with a trained clinician and will take place during the first three months of the participant's loved ones' transplant process. A trained behavioral psychologist or social worker will meet with the participant or talk with the participant over the telephone or video conference for 45 minutes at a time to discuss the participant's caregiver experience and to help the participant develop effective skills to support the participant's loved one as well as participant over the course of the transplant. The study will use a series of questionnaires to measure the participant's quality of life, mood, and overall caregiving burden. Study questionnaires will be completed in the hospital or clinic. The participant will also have the option of completing these questionnaires remotely through a secure web link, over the telephone, or in a mailed paper copy.

Official Title
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Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Conditions
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Cancer

Intervention / Treatment
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* Other: CARE
* Other: Standard Transplant Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult caregivers (≥18 years) of patients undergoing autologous or allogeneic HCT at MGH, and they must attend the HCT consent visit with the patient. 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. Ability to speak English or able to complete questionnaires with minimum assistance of an interpreter. Exclusion Criteria: • Significant uncontrolled psychiatric or other co-morbid disease, which the primary oncologist believes prohibits the ability to participate in study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARE intervention<br>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 | Other: CARE<br>* Promote effective coping and reduce caregiving burden.<br>|
| Active Comparator: Standard transplant care<br>Standard Transplant Care Social work consults to help caregivers only upon request | Other: CARE<br>* Promote effective coping and reduce caregiving burden.<br>Other: Standard Transplant Care<br>* Standard cared administered by the hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention (feasibility description below) | Feasibility defined if at least 60% of eligible caregivers are enrolled in the study and attend at least 50% of the intervention visits | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Caregiver QOL (CarGOQOL) between the study arms | we will compare caregiver QOL as measured by CarGOQOL at day +30 and day +90 after the intervention (adjusting for baseline values) | up to day +90 | 
| Compare caregiving burden (CRA) between the study arms | we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA) at day +30 and day +90 after the intervention (adjusting for baseline values) | up to day +90 | 
| Compare caregiver mood (HADS) between the study arms | We will compare caregiver mood use the Hospital Anxiety and Depression Scale (HADS) at day +30 and day +90 (controlling for baseline values). The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress)) | up to day +90 | 
| Compare caregiver self-efficacy (CASE-t) between the study arms | We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) at day +30 and day +90 (controlling for baseline values). The scale ranges from 0 to 170 with higher scores indicate higher self efficacy | up to day +90 | 
| Compare perceived coping skills (MOCS) between the study arms | Compare caregiver coping skills using the Measure of Current Status (MOCS) between the study arms. Score ranges from 0-52, with higher scores indicating higher coping skills | up to day +90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Care