Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03735498

Collaborator

(none)

Enrollment

Location

Arm

13.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma	Other: Psychological Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Actual Study Start Date :

Feb 8, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psychological Intervention Qualitative interview will be conducted 7-item Generalized Anxiety Disorder measure will be completed by participants via mail correspondence or online A psychoeducational component to address preparedness, manage 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: Psychological Intervention Promote effective coping and reduce caregiving burden

Arm

Intervention/Treatment

Experimental: Psychological Intervention

Qualitative interview will be conducted 7-item Generalized Anxiety Disorder measure will be completed by participants via mail correspondence or online A psychoeducational component to address preparedness, manage 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: Psychological Intervention

Promote effective coping and reduce caregiving burden

Outcome Measures

Primary Outcome Measures

Feasibility of caregiver enrollment in the intervention: Proportion of eligible caregivers who agree to participate in the study of this intervention [2 years]
The investigators will report the proportion 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.
Feasibility of caregiver participation in a population-specific psychological intervention: Proportion of eligible caregivers who participate in each session [2 years]
The investigators will report the proportion 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥ 18
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02214

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Deborah A. Forst, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deborah A Forst, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT03735498

Other Study ID Numbers:

18-426

First Posted:

Nov 8, 2018

Last Update Posted:

Apr 17, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Deborah A Forst, Principal Investigator, Massachusetts General Hospital

Malignant Gliomas

Additional relevant MeSH terms:

Glioma

Study Results

No Results Posted as of Apr 17, 2020