Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Malignant Glioma Clinical Trial

Official title:

Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735498
• Other study ID #: 18-426
• Secondary ID: U24NR014637
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Other:
• Psychological Intervention
Promote effective coping and reduce caregiving burden

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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