NCT03244995

Mind-Body Intervention in Glioma Couples

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Mind-Body Intervention Procedure	Undergo CBMB program
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-08-06
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2017-08-10
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States