Psychological Intervention for Caregivers of Patients With Malignant Gliomas

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

Study Overview

• Status: Completed
• Conditions: Malignant Glioma
• Intervention / Treatment: Other: Psychological Intervention

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention	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.	2 years
Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session	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.	2 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Nursing Research (NINR); Palliative Care Research Cooperative Group
• Investigators: Principal Investigator: Deborah A. Forst, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2019
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (ACTUAL): November 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Malignant Gliomas
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: 18-426; U24NR014637 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No