Psychological Intervention for Caregivers of Patients With Malignant Gliomas

NCT ID: NCT03735498

Last Updated: 2024-11-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2020-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Malignant Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Psychological Intervention

Intervention Type OTHER

Promote effective coping and reduce caregiving burden

Interventions

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Psychological Intervention

Promote effective coping and reduce caregiving burden

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Palliative Care Research Cooperative Group

NETWORK

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deborah A Forst

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah A. Forst, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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U24NR014637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-426

Identifier Type: -

Identifier Source: org_study_id

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