Glioblastoma, Low Grade Glioma, Malignant Glioma, Metastatic Malignant Neoplasm in the Brain, Partner, WHO Grade III Glioma
Conditions
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.
Interventions
PROCEDUREMind-Body Intervention Procedure
Undergo CBMB program
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual | Up to 6 weeks | Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable. |
| Feasibility of CBMB program as determined by attrition | Up to 6 weeks | Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable. |
| Feasibility of CBMB program as determined by adherence | Up to 6 weeks | Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable. |
| Feasibility of CBMB program as determined by acceptability | Up to 6 weeks | 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. |
| CBMB program efficacy | Up to 6 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathrin Milbury
M.D. Anderson Cancer Center
Outcome results
None listed