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Esophageal CarcinomaNCT04607590

Yoga Program for Improving the Quality of Life in Couples Coping With Cancer

A study testing Best Practice, Quality-of-Life Assessment and Questionnaire Administration in people with Esophageal Carcinoma and Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Best Practice, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
31 May 2019to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • PATIENTS ONLY: Diagnosed with a lung cancer, head and neck cancer, or esophageal cancer to receive at least 25 fractions over 5 weeks of radiation therapy (RT)
  • PATIENTS ONLY: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • PATIENTS ONLY: Having a spouse or cohabitating partner (same or opposite sex) willing to participate
  • PATIENTS AND PARTNERS: Must be at least 18 years old
  • PATIENTS AND PARTNERS: Must be able to read and speak English
  • PATIENTS AND PARTNERS: Must be able to provide informed consent

Who cannot join

  • PATIENTS ONLY: Who have regularly (self-defined) participated in a mind-body practice or exercise program in the year prior to diagnosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Yoga Program for Couples Coping With Cancer

This clinical trial seeks to learn if a yoga program can improve physical performance, quality of life and symptom burden in cancer patients who are undergoing radiation therapy, and their partners. Taking part in yoga or stretching sessions may lower distress, improve quality of life, and/or may improve sleep and fatigue for cancer patients and their caregivers.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To examine the extent to which the dyadic yoga (DY) program improves patient objective physical performance as compared to the waitlist control (WLC) group (primary comparison) and the patient-only yoga (PY) group (exploratory comparison).

SECONDARY OBJECTIVE:

  1. To examine the extent to which the DY program improves patient and partner quality of life (QOL) compared to the WLC group (primary comparison) and the PY group (exploratory comparison).

TERTIARY OBJECTIVE:

  1. To examine the extent to which the DY program reduces patient healthcare utilization (i.e., emergency room visits, hospital admissions, and feeding tube insertions) and patient and partner work productivity compared to the WLC group (primary comparison) and the PY group (exploratory comparison).

EXPLORATORY OBJECTIVE:

  1. To explore if, compared to the WLC and PY groups, the DY program improves symptom burden and symptom management skills at the end of treatment, which will in turn mediate intervention outcomes at the subsequent follow-up assessments.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I (DY): Patients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.

GROUP II (PY): Patients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners are offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.

GROUP III (WLC): Patients and their partner receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.

After completion of radiation therapy, patients are followed up at 1 , 2, 3, and 6 months.

Being tested
Best Practice, Quality-of-Life Assessment, Questionnaire Administration, Yoga
Medical subject headings
Esophageal Neoplasms, Lung Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual care

  • Quality-of-Life AssessmentProcedure or surgery

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • YogaProcedure or surgery

    Also called Yoga Therapy

    Participate in yoga sessions

Study groups in NCT04607590
Study groupRoleWhat they receive
Group I (DY)ExperimentalPatients and their partners attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy.
Receives: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Yoga
Group II (PY)ExperimentalPatients attend yoga sessions 3 days per week for up to 15 sessions, lasting 60 minutes each, in-person or via videoconferencing over the course of radiation therapy. Once data collection is completed, partners will be offered intervention materials, and encouraged to attend yoga classes at the Integrative Medicine Clinic.
Receives: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Yoga
Group III (WLC)ExperimentalPatients and their partners receive usual care. Once data collection is completed, couples may participate in the DY or PY program of their choice over 60 minutes each. Partners are also offered intervention materials along with five 60 minute optional yoga sessions.
Receives: Other: Best Practice; Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU)

    This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) modeling (MLM) analysis, with repeated measures over time (i.e., at end of treatment, 3- and 6-month follow-ups). Potential interaction terms will be included and tested, in particular, between the intervention and time. The repeated measures correlation structure will be selected using the Bayesian information criterion (BIC). The difference between dyadic yoga (DY) and waitlist control (WLC) at 3MFU is considered the primary and confirmatory comparison and will be tested at a two-sided 0.025 significance level. Additionally, on an exploratory basis, will conduct an omnibus test on the overall differences in 6MWT across the three groups at 3-month follow-up, as well as pairwise comparisons between the patient yoga (PY) and WLC and between DY and PY. Exploratory comparisons will be primarily interpreted based on clinically significant difference, which is 70m for the study population.

    Measured: At the 3-month follow-up

Secondary outcomes (1)

  1. Patient and partner short form survey (SF-36) domains

    Analyses will be similar to those for the primary outcome, except that will use a dyadic model assuming additional dependence in outcomes between patient and partner outcomes. Repeated measures over time will include at the end of treatment, 1-, 3- and 6-month follow-ups. Will examine the individual SF-36 domains as well as the physical (PCS) and mental component summaries (MCS). Patient and partner overall quality of life (QOL) will be measured with the Medical Outcomes Study 36-item short-form survey (SF-36) assessing 8 distinct domains: physical functioning, physical impediments to role functioning, pain, general health perceptions, vitality, social functioning, emotional impediments to role functioning, and mental health. The SF-36 will take up to 7 minutes to complete and will be assessed at each follow-up time point (time point 1 [T1] - time point 6 [T6]).

    Measured: At each follow-up time point (1 month follow-up to 6-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start31 May 2019
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607590
Sponsor's protocol ID
2018-0887
Other IDs
NCI-2020-02943, 2018-0887
Status last verified
Jul 2026
First submitted
20 May 2020
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Quality-of-Life Assessment and Questionnaire Administration in people with Esophageal Carcinoma and Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The patient 6-minute walk test (6-MWT) over the 6-month follow up (6-MFU) (time frame: At the 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04607590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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