Psychological Intervention For Brain Tumor Caregivers

November 1, 2023 updated by: Deborah A Forst, Massachusetts General Hospital

NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)

This study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. This study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones.

The purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.

Study Overview

Detailed Description

This study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care.

The aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. The study will be conducted in 120 caregivers.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18
  • Identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver
  • The patient is receiving care at the MGH Cancer Center
  • The patient was diagnosed with a malignant brain tumor 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
  • Participated in the pilot study of this caregiver intervention (DF/HCC 18-426)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care Group
  • 60 Participants will be randomized to receive usual care for caregivers of patients with malignant brain tumors
  • Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician
  • Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks

Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician

•Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks

Experimental: Psychosocial Intervention Group
  • 60 Participants of caregivers of patients with malignant brain tumors will be randomized into the psychosocial intervention arm
  • Caregivers assigned to the intervention arm will receive usual care and the psychosocial intervention. The intervention entails six one-on-one sessions with an interventionist (psychologist or social worker)
  • Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms
Time Frame: 11 weeks
We will compare anxiety symptoms using the Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS-A) between the intervention and usual care group. The HADS-A is a 7-item subscale with scores ranging from 0 to 21, with higher scores indicating higher levels of anxiety.
11 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms longitudinally
Time Frame: Up to 16 weeks
We will compare anxiety symptoms using the Anxiety subscale of the hospital anxiety and depression scale (HADS-A) between the two groups longitudinally. HADS-A is the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
Up to 16 weeks
Self-Efficacy
Time Frame: Up to 16 weeks
Comparison of the effect of the intervention on caregiver self-efficacy (CASE) between study groups . The Lewis Cancer Self-Efficacy Scale (CASE) is a 17-item scale that measures caregivers' confidence in managing the impact of their loved one's illness from. Score range from 0 to 170. Higher scores indicate higher self-efficacy.
Up to 16 weeks
Coping skills
Time Frame: Up to 16 weeks
We will compare coping skills between study arms using the Measure of Current Status Part A (MOCS-A). The MOCS-A assesses caregivers' self-perceived status on coping skills targeted by the intervention. Total MOCS-A scores range from 0-52 with higher scores indicating better self-perceived coping skills.
Up to 16 weeks
Quality of life using the Caregiver quality of life oncology questionnaire
Time Frame: Up to 16 weeks
Comparison of caregiver quality of life (CarGOQoL) between study groups. The CareGiver Oncology QoL questionnaire (CarGOQoL) is a 29-item, well-validated instrument specific to caregivers for patients with cancer, used to measure family caregiver QoL in multiple domains. Overall scores range from 0 to 100, with higher scores corresponding to higher quality of life.
Up to 16 weeks
Caregiver burden
Time Frame: Up to 16 weeks

Comparison of caregiver burden (CRA) between study groups.

- Caregiving burden will be measured using the Caregiver Reaction Assessment (CRA), a 24-item scale measuring caregiving burden with score range of 24-120. Higher scores indicate higher caregiving burden.

Up to 16 weeks
Depression symptoms
Time Frame: Up to 16 weeks
Comparison of the effect of the intervention on depression symptoms (HADS-D) between study groups. HADS-D is the 7-item depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating higher levels of depression.
Up to 16 weeks
PTSD symptoms
Time Frame: Up to 16 weeks
Comparison of post-traumatic stress disorder (PTSD) symptoms between study groups . PTSD symptoms will be measured using the PCL-5, a 20-item questionnaire with scores ranging from 0-80; higher scores indicate more severe PTSD symptoms.
Up to 16 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: 11 weeks
For participants who are assigned to the intervention arm, we will use the Client Satisfaction Questionnaire (CSQ-3), a three-item questionnaire designed to evaluate satisfaction with provision, quality, and outcome of services, to assess participant acceptability of the NeuroCARE intervention. Total scores on the CSQ-3 range from 4-12, with higher numbers indicating a higher level of satisfaction with the services provided.
11 weeks
Exploratory Moderation Analysis
Time Frame: Up to 16 weeks
As an exploratory analysis, we will assess whether age, sex, and baseline anxiety moderate the effect of the intervention on caregiver reported outcomes
Up to 16 weeks
Exploratory Causal Mediation Analysis
Time Frame: Up to 16 weeks
Exploratory causal mediation analysis to explore whether caregiver self-efficacy and coping skills mediate the effect of the intervention on caregiver anxiety symptoms.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deborah Forst, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2019

Primary Completion (Actual)

September 13, 2022

Study Completion (Actual)

September 13, 2022

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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