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Active, Not Recruiting

NCT Number: NCT03244995

Mind-Body Intervention in Glioma Couples

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Low Grade Glioma Malignant Glioma Metastatic Malignant Neoplasm in the Brain Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Partner WHO Grade III Glioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mind-body intervention procedure

Procedure

Undergo CBMB program

Other names: Mind-Body Interventions, Mind-Body Medicine

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of couple-based mind-body program (CBMB) as determined by overall accrual

    Time frame: Up to 6 weeks

    Trial considered feasible if 50% of eligible couples consent. Will calculate rates, frequencies, and 90% confidence intervals (CIs), as applicable.

  2. Feasibility of CBMB program as determined by attrition

    Time frame: 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.

  3. Feasibility of CBMB program as determined by adherence

    Time frame: Up to 6 weeks

    Trial considered feasible if 50% of all sessions are attended. Will calculate rates, frequencies, and 90% CIs, as applicable.

  4. Feasibility of CBMB program as determined by acceptability

    Time frame: 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.

  5. CBMB program efficacy

    Time frame: 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.

Other outcomes

  1. CBMB program efficacy on quality of life (QOL) outcomes

    Time frame: Up to 3 months after completion of study

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2017
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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