Mind-Body Intervention in Glioma Couples

NCT03244995 | Active Not Recruiting

• 2 other identifiers: 2017-0290NCI-2018-01099
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• CBMB program efficacy on quality of life (QOL) outcomes

  Up to 3 months after completion of study

Study Arms (2)

Group I (CBMB program)

EXPERIMENTAL

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.

Procedure: Mind-Body Intervention Procedure; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (waitlist control)

ACTIVE COMPARATOR

Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (CBMB program); Group II (waitlist control)

Mind-Body Intervention Procedure PROCEDURE

Undergo CBMB program

Also known as: Mind-Body Interventions, Mind-Body Medicine

Group I (CBMB program)

Questionnaire Administration OTHER

Ancillary studies

Group I (CBMB program); Group II (waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Glioblastoma; Glioma; Brain Neoplasms

Interventions

Mind-Body Therapies

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Kathrin Milbury

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: August 6, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 2, 2026

Record last verified: 2025-08

Locations

US (1)