Psychological Intervention For Brain Tumor Caregivers
- Conditions
- Malignant GliomaAnxietyCaregiver BurdenMalignant Brain Tumor
- Interventions
- Behavioral: Usual Care GroupBehavioral: Psychosocial Intervention Group
- Registration Number
- NCT04109209
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Group 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 Psychosocial Intervention Group 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
- Primary Outcome Measures
Name Time Method Anxiety symptoms 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.
- Secondary Outcome Measures
Name Time Method Self-Efficacy 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.
Anxiety symptoms longitudinally 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.
Quality of life using the Caregiver quality of life oncology questionnaire 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.
Caregiver burden 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.Coping skills 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.
Depression symptoms 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.
PTSD symptoms 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.
Trial Locations
- Locations (1)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States