Psychological Intervention For Brain Tumor Caregivers

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109209
• Other study ID #: 19-250
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: September 13, 2022

Study information

• Verified date: November 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 13, 2022
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Brain Neoplasms
• Caregiver Burden
• Glioma
• Malignant Brain Tumor
• Malignant Glioma

Intervention

Behavioral:
• Psychosocial Intervention Group
The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
• Usual Care Group
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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Acceptability	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
Other	Exploratory Moderation Analysis	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
Other	Exploratory Causal Mediation Analysis	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
Primary	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.	11 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks
Secondary	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.	Up to 16 weeks