Mind-Body Intervention in Glioma Couples
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma
- Low Grade Glioma
- Malignant Glioma
- Metastatic Malignant Neoplasm in the Brain
- Partner
- WHO Grade III Glioma
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 qua...
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.
Tracking Information
- NCT #
- NCT03244995
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Kathrin Milbury M.D. Anderson Cancer Center