Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
NCT Number: NCT04109209
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will consist of six one-on-one sessions (45 minutes each). 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
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.
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.
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.
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.
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.
Time frame: Up to 16 weeks
Comparison of caregiver burden (CRA) between study groups.
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.
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.
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.
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
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.
Massachusetts General Hospital
Other
NeuroCARE: Psychological Intervention for Caregivers of Patients With Malignant Gliomas (RCT)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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