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Psychological Intervention For Brain Tumor Caregivers

Primary Purpose

Malignant Glioma, Anxiety, Caregiver Burden

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Intervention Group
Usual Care Group
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 Glioma, Caregiver Anxiety, Caregiver Burden, Psychological distress, Brain Tumor

Eligibility Criteria

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

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)

Sites / Locations

  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care Group

Psychosocial Intervention Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anxiety symptoms
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.

Secondary Outcome Measures

Anxiety symptoms longitudinally
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.
Self-Efficacy
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.
Coping skills
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.
Quality of life using the Caregiver quality of life oncology questionnaire
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.
Caregiver burden
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.
Depression symptoms
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.
PTSD symptoms
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.

Full Information

First Posted
September 26, 2019
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Conquer Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04109209
Brief Title
Psychological Intervention For Brain Tumor Caregivers
Official Title
NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
September 13, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Conquer Cancer Foundation

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Anxiety, Caregiver Burden, Malignant Brain Tumor
Keywords
Malignant Glioma, Caregiver Anxiety, Caregiver Burden, Psychological distress, Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Psychosocial Intervention Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Intervention Group
Intervention Description
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Anxiety symptoms
Description
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.
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Anxiety symptoms longitudinally
Description
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.
Time Frame
Up to 16 weeks
Title
Self-Efficacy
Description
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.
Time Frame
Up to 16 weeks
Title
Coping skills
Description
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.
Time Frame
Up to 16 weeks
Title
Quality of life using the Caregiver quality of life oncology questionnaire
Description
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.
Time Frame
Up to 16 weeks
Title
Caregiver burden
Description
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.
Time Frame
Up to 16 weeks
Title
Depression symptoms
Description
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.
Time Frame
Up to 16 weeks
Title
PTSD symptoms
Description
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.
Time Frame
Up to 16 weeks
Other Pre-specified Outcome Measures:
Title
Intervention Acceptability
Description
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.
Time Frame
11 weeks
Title
Exploratory Moderation Analysis
Description
As an exploratory analysis, we will assess whether age, sex, and baseline anxiety moderate the effect of the intervention on caregiver reported outcomes
Time Frame
Up to 16 weeks
Title
Exploratory Causal Mediation Analysis
Description
Exploratory causal mediation analysis to explore whether caregiver self-efficacy and coping skills mediate the effect of the intervention on caregiver anxiety symptoms.
Time Frame
Up to 16 weeks

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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Forst, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.partners.org/innovation

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Psychological Intervention For Brain Tumor Caregivers

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