Mind-Body Intervention in Glioma Couples

Study Overview
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Brief Summary
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This trial studies how well a couple-based mind body program works in improving spiritual, psychosocial, and physical quality of life in patients with high or low grade glioma or tumors that have spread to the brain and their partners. A couple-based mind body program may help to improve spiritual well-being, sleep difficulties, depressive symptoms, and overall quality of life in patients with glioma or tumors that have spread to the brain and their partners.

Detailed Description
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PRIMARY OBJECTIVES: I. Examine the feasibility of the couple-based mind-body (CBMB) program in patients with high grade glioma (HGG) and their partners. II. Establish the initial efficacy of the CBMB program in patients and their partners regarding spiritual (primary), psychological and physical quality of life (QOL) (secondary) outcomes relative to a waitlist control (WLC) group. EXPLORATORY OBJECTIVES: I. Explore potential mediation (i.e., mindfulness, compassion, holding back, and intimacy) and moderation (e.g., baseline medical, demographic and psychosocial factors) effects of the intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (CBMB PROGRAM): Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life. GROUP II (WAITLIST CONTROL): Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study. After completion of study, patients are followed up at 3 months.

Official Title
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An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners

Conditions
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Partner, Glioblastoma, Low Grade Glioma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain, WHO Grade III Glioma

Intervention / Treatment
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* Procedure: Mind-Body Intervention Procedure
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENT ONLY: Patients with a diagnosis of HGG or low grade glioma (LGG), based on radiographic or pathologic diagnosis of grade III or IV listed in the medical records, or patients with a malignancy that has metastasized to the brain PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy) PATIENT ONLY: Karnofsky performance status (KPS) of 80 or above PATIENT ONLY: Having a spouse/romantic partner (including same-sex) and who is willing to participate PATIENT & PARTNER: Able to read and speak English PATIENT & PARTNER: Able to provide informed consent PATIENT & PARTNER: Have access to internet connectivity Exclusion Criteria: PATIENT ONLY: Regularly (self-defined) participation in psychotherapy or a formal cancer support group PATIENT ONLY: Cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (CBMB program)<br>Patients undergo CBMB program consisting of 4-5 deep-breathing and meditation exercise sessions over 60 minutes and 2 weekly telephone calls over 15 minutes for 6 weeks. Patients also complete questionnaires regarding health, mood, sleeping habits, relationship, health care, work productivity, and quality of life. | Procedure: Mind-Body Intervention Procedure<br>* Undergo CBMB program<br>* Other names: Mind-Body Medicine;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (waitlist control)<br>Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual | Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable. | Up to 6 weeks | 
| Feasibility of CBMB program as determined by attrition | Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks | 
| Feasibility of CBMB program as determined by adherence | Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks | 
| Feasibility of CBMB program as determined by acceptability | Trial considered feasible if > 75% of patients in the CBMB group rate the intervention as acceptable. Will calculate rates, frequencies, and 90% CIs, as applicable. | Up to 6 weeks | 
| CBMB program efficacy | Will calculate effect sizes for pairwise between-group comparisons of intervention outcomes at T2. Will test for between-group differences in the change of scores between T1 and T2 using analysis of variance. | Up to 6 weeks |