Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 1:57 PM
Ignite Modification Date: 2025-12-24 @ 1:57 PM
NCT ID: NCT03244995
Brief 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.
Study: NCT03244995
Study Brief:
Protocol Section: NCT03244995