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Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT03328663
Recruitment Status : Recruiting
First Posted : November 1, 2017
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Other: CARE Other: Standard Transplant Care Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Psychological Intervention to Promote Coping for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HCT)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: CARE 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
Other: CARE
Promote effective coping and reduce caregiving burden.

Active Comparator: Standard transplant care
  • Standard Transplant Care
  • Social work consults to help caregivers only upon request
Other: CARE
Promote effective coping and reduce caregiving burden.

Other: Standard Transplant Care
Standard cared administered by the hospital.




Primary Outcome Measures :
  1. Feasibility of the intervention (feasibility description below) [ Time Frame: 2 years ]
    Feasibility defined if at least 60% of eligible caregivers are enrolled in the study and attend at least 50% of the intervention visits


Secondary Outcome Measures :
  1. Compare Caregiver QOL (CarGOQOL) between the study arms [ Time Frame: up to day +90 ]
    we will compare caregiver QOL as measured by CarGOQOL at day +30 and day +90 after the intervention (adjusting for baseline values)

  2. Compare Caregiver QOL (SF-36) between the study arms [ Time Frame: up to day +90 ]
    we will compare caregiver QOL as measured by SF-36 at day +30 and day +90 after the intervention (adjusting for baseline values)

  3. Compare caregiving burden (CRA) between the study arms [ Time Frame: up to day +90 ]
    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)

  4. Compare caregiver mood (HADS) between the study arms [ Time Frame: up to day +90 ]
    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))

  5. Compare caregiver self-efficacy (CASE-t) between the study arms [ Time Frame: up to day +90 ]
    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

  6. Compare stress management scale (Health-Promoting Lifestyle Profile II) between the study arms [ Time Frame: up to day +90 ]
    Compare caregiver stress management using the stress management scale of the Health-Promoting Lifestyle Profile II at day +30 and day +90 (controlling for baseline values). The scale ranges from 8 to 32 with higher scores indicating better stress management skills.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03328663


Contacts
Contact: Areej El-Jawahri, MD 617-643-4003 ael-jawahri@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri, MD    617-643-4003    ael-jawahri@partners.org   
Principal Investigator: Areej El-Jawahri, MD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital

Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03328663     History of Changes
Other Study ID Numbers: 17-476
CA087723 ( Other Grant/Funding Number: NCI )
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Cancer Care