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Psychological Intervention for Caregivers of Patients With Malignant Gliomas

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychological Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Glioma focused on measuring Malignant Gliomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychological Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2018
Last Updated
September 14, 2022
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT03735498
Brief Title
Psychological Intervention for Caregivers of Patients With Malignant Gliomas
Official Title
Psychological Intervention for Caregivers of Patients With Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Nursing Research (NINR), Palliative Care Research Cooperative Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
Malignant Gliomas

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychological Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Psychological Intervention
Intervention Description
Promote effective coping and reduce caregiving burden
Primary Outcome Measure Information:
Title
Feasibility of Caregiver Enrollment in the Intervention: Percentage of Eligible Caregivers Who Agree to Participate in the Study of This Intervention
Description
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.
Time Frame
2 years
Title
Feasibility of Caregiver Participation in a Population-specific Psychological Intervention: Percentage of Eligible Caregivers Who Participate in Each Session
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah A. Forst, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Psychological Intervention for Caregivers of Patients With Malignant Gliomas

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