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Clinical Trials/NCT03735498
NCT03735498
Completed
Not Applicable

Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Massachusetts General Hospital1 site in 1 country13 target enrollmentFebruary 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Glioma
Sponsor
Massachusetts General Hospital
Enrollment
13
Locations
1
Primary Endpoint
Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session
Status
Completed
Last Updated
last year

Overview

Brief Summary

This research study is evaluating a psychological intervention for caregivers of loved ones with malignant gliomas.

Detailed Description

Caregivers of loved ones with malignant gliomas frequently experience a physical and psychological burden caring for their loved ones. The purpose of this study is to find out whether a psychological intervention can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable. The psychological intervention will take place in a series of six sessions. A trained social worker or psychologist will meet with the participant or talk with the participant over the telephone or by video conference for 45 minutes at a time to discuss the caregiver experience while developing effective skills to support the loved one as well as the participant over the course of the loved one's illness. Upon the completion of the sessions, the investigators will have a short (30-minute) exit interview to obtain the participant's feedback on the intervention. The investigators will use the feedback to improve the intervention before further testing its effectiveness in future research studies. The investigators will also ask the participant to complete questionnaires before and after their participation in the intervention to help the investigators understand the participant's coping skills, caregiving burden, mood, and understanding about the loved one's illness.

Registry
clinicaltrials.gov
Start Date
February 8, 2019
End Date
March 30, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah A Forst

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Identified by a patient with a malignant glioma (WHO Grade III or IV glioma) as the patient's primary caregiver
  • The patient is receiving care at the MGH Cancer Center
  • The patient was diagnosed with a malignant glioma within the past 6 months
  • Able to speak and read in English
  • Generalized Anxiety Disorder 7-item (GAD-7) score ≥5
  • Participants may or may not be pregnant.

Exclusion Criteria

  • Deemed inappropriate for the study by the patient's clinician or the study PI

Outcomes

Primary Outcomes

Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session

Time Frame: 2 years

The investigators will report the percentage of eligible caregivers who participate in each session. Participation will be considered feasible if at least 70% of enrolled participants complete ≥50% of the sessions.

Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention

Time Frame: 2 years

The investigators will report the percentage of eligible caregivers who agree to participate in the study of this intervention. The intervention will be deemed feasible if at least 70% (+/- 18%) of eligible caregivers are enrolled in the study.

Study Sites (1)

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