Mind-Body Intervention in Glioma Couples

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03244995
• Other study ID #: 2017-0290
• Secondary ID: NCI-2018-0109920
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 6, 2017
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Mind-Body Intervention Procedure
Undergo CBMB program

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CBMB program efficacy on quality of life (QOL) outcomes	Will examine treatment mediators and moderators. Will examine if treatment efficacy on QOL outcomes measured at T3 is potentially achieved through improved mindfulness, self-compassion, holding back and intimacy measured at T2 using linear regression analysis in both a and b paths. Ninety percent bootstrap CIs will be constructed to assess the significance of the indirect effects defined using the product-of-coefficient approach. Linear regression analysis or multi-level modeling will be used to test for the interaction effects between treatment and baseline mindfulness, self-compassion, holding back and intimacy, as well as baseline medical and demographic factors (i.e., sex, age, and Karnofsky performance status), each at a two-sided significance level of 0.1.	Up to 3 months after completion of study
Primary	Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual	Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.	Up to 6 weeks
Primary	Feasibility of CBMB program as determined by attrition	Trial considered feasible if 80% of enrolled couples complete T1 and T2 assessments. Will calculate rates, frequencies, and 90% CIs, as applicable.	Up to 6 weeks
Primary	Feasibility of CBMB program as determined by adherence	Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.	Up to 6 weeks
Primary	Feasibility of CBMB program as determined by acceptability	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.	Up to 6 weeks
Primary	CBMB program efficacy	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.	Up to 6 weeks

External Links

•   MD Anderson Cancer Center