Clinical trial NCT03244995: Mind-Body Intervention in Glioma Couples
Official title: An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glioblastoma
Low Grade Glioma
Malignant Glioma
Metastatic Malignant Neoplasm in the Brain
Partner
WHO Grade III Glioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-08-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual
timeFrame: Up to 6 weeks
measure: Feasibility of CBMB program as determined by attrition
timeFrame: Up to 6 weeks
measure: Feasibility of CBMB program as determined by adherence
timeFrame: Up to 6 weeks
measure: Feasibility of CBMB program as determined by acceptability
timeFrame: Up to 6 weeks
measure: CBMB program efficacy
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
measure: CBMB program efficacy on quality of life (QOL) outcomes
timeFrame: Up to 3 months after completion of study
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathrin Milbury
role: PRINCIPAL_INVESTIGATOR
References: