Mind-Body Intervention in Glioma Couples

February 8, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Mind-Body Intervention Procedure
Undergo CBMB program
Other Names:
  • Mind-Body Interventions
  • Mind-Body Medicine
Active Comparator: Group II (waitlist control)
Patients complete questionnaires as in Group I. Patients may undergo CBMB program after completion of study.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 weeks
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.
Up to 6 weeks
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.
Up to 6 weeks
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.
Up to 6 weeks
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.
Up to 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months after completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kathrin Milbury, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2017

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0290 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-01099 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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