deltatrials
Active Not Recruiting INTERVENTIONAL NCT02481349

Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners

Couple-Based Yoga Program for Glioma Patients and Their Partners

Sponsor: M.D. Anderson Cancer Center

Updated 23 times since 2017 Last updated: Apr 10, 2026 Started: Jun 16, 2015 Primary completion: Apr 30, 2027 Completion: Apr 30, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Caregiver and Glioma, this trial is ongoing. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 23 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. Examine the feasibility of a couple-based and a caregiver yoga program in glioma patients undergoing radiotherapy (RT) and their partners. SECONDARY OBJECTIVES: I. Establish the initial efficacy of the yoga program in patients and their partners regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL and health care utilization). EXPLORATORY OBJECTIVES: I. Explore potential moderation (e.g., baseline psychological distress, patients' tumor grade, performance status and class attendance) of the intervention effects. OUTLINE: The first five couples are assigned to arm I. All subsequent couples are randomized to 1 of 2 arms. ARM I: Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a digital video disc (DVD) and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor. ARM II: Patients receive standard of care provided by the health care...

PRIMARY OBJECTIVES:

I. Examine the feasibility of a couple-based and a caregiver yoga program in glioma patients undergoing radiotherapy (RT) and their partners.

SECONDARY OBJECTIVES:

I. Establish the initial efficacy of the yoga program in patients and their partners regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL and health care utilization).

EXPLORATORY OBJECTIVES:

I. Explore potential moderation (e.g., baseline psychological distress, patients' tumor grade, performance status and class attendance) of the intervention effects.

OUTLINE: The first five couples are assigned to arm I. All subsequent couples are randomized to 1 of 2 arms.

ARM I: Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a digital video disc (DVD) and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor.

ARM II: Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshot~Aug 2017 – ~Jan 2018 · 5 months · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jun 2019 · 6 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Aug 2020 · 12 months · monthly snapshot~Aug 2020 – ~Dec 2020 · 4 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Sep 2022 · 20 months · monthly snapshot~Sep 2022 – ~Mar 2023 · 6 months · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Nov 2023 · 6 months · monthly snapshot~Nov 2023 – ~May 2024 · 6 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~May 2025 · 6 months · monthly snapshot~May 2025 – ~Nov 2025 · 6 months · monthly snapshot~Nov 2025 – ~Apr 2026 · 5 months · monthly snapshotApr 16, 2026 – present · 4 months · daily API

Change History

23 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Active Not Recruiting

    Phase: NANone

  2. Nov 2025 — Apr 2026 [monthly]

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  3. May 2025 — Nov 2025 [monthly]

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  4. Nov 2024 — May 2025 [monthly]

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  5. Sep 2024 — Nov 2024 [monthly]

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Show 18 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

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  16. Jan 2018 — Jun 2018 [monthly]

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  17. Aug 2017 — Jan 2018 [monthly]

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  18. Jan 2017 — Aug 2017 [monthly]

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    First recorded

Jun 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This randomized clinical trial studies couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners. A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.

Contact Information

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations