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Completed

NCT Number: NCT03328663

Psychological Intervention for Caregivers of Patients Undergoing Stem Cell Transplant

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARE

Other

Promote effective coping and reduce caregiving burden.

Standard Transplant Care

Other

Standard cared administered by the hospital.

Primary outcomes

  1. Feasibility of the Intervention (Feasibility Description Below)

    Time frame: 15 months

    Feasibility defined if eligible caregivers randomized to intervention attend at least 50% of the intervention visits

Secondary outcomes

  1. Compare Caregiver Quality of Life (QOL) as Measured by the Caregiver Oncology QOL (CarGOQOL) Questionnaire Between the Study Arms

    Time frame: day 60

    we will compare caregiver QOL as measured by CarGOQOL between study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL

  2. Compare Caregiving Burden (CRA) Between the Study Arms

    Time frame: day 60

    we will compare caregiver caregiving burden as measured by Caregiver Reaction Assessment (CRA). The CRA ranges from 24-120 with higher scores indicating greater caregiving burden

  3. Compare Caregiver Anxiety Using Hospital Anxiety and Depression Scale (HADS) Between the Study Arms

    Time frame: day 60

    We will compare caregiver anxiety use the Hospital Anxiety and Depression Scale (HADS) between the two groups. The HADS includes two subscales: depression (range 0 (no distress) to 21 (maximum distress) and anxiety (range 0 (no distress) and 21 (maximum distress)). Higher scores on HADS-Anxiety subscale indicate worse anxiety symptoms.

  4. Compare Caregiver Self-efficacy Using the Cancer Self-Efficacy Scale-Transplant (CASE-t) Between the Study Arms

    Time frame: day 60

    We will compare caregiver self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between study groups. The scale ranges from 0 to 170 with higher scores indicate higher self efficacy.

  5. Compare Perceived Coping Skills (MOCS) Between the Study Arms

    Time frame: day 60

    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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2024
First posted
Nov 1, 2017
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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