Head and Neck CarcinomaNCT04890834
Dyadic Yoga Intervention for the Improvement of Healthcare Utilization and Quality of Life in Patients With Head and Neck Cancer Undergoing Chemoradiation and Their Caregivers
A study testing Best Practice, Exercise Intervention and Questionnaire Administration in people with Head and Neck Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Best Practice, Exercise Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 30 Jun 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: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
- PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
- PATIENTS AND CAREGIVERS: Must be at least 18 years old
- PATIENTS AND CAREGIVERS: Able to read and speak English
- PATIENTS AND CAREGIVERS: Able to provide informed consent
Who cannot join
- PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Healthcare Utilization and Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation and Their Family Caregivers
This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.
Read the detailed description
PRIMARY OBJECTIVES:
- Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.
II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.
III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.
IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.
ARM II: Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.
After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Best Practice, Exercise Intervention, Questionnaire Administration
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 standard care
Participate in yoga sessions
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Standard of care) | Active comparator | Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed. Receives: Other: Best Practice; Other: Questionnaire Administration |
| Arm II (exercise, yoga sessions) | Other | Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions. Receives: Other: Best Practice; Other: Exercise Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient healthcare utilization (Standard of care)
Will examine group differences in patient emergency department visit (yes/no) during the observation period of during and up to 3 months post chemoradiotherapy (CRT) as the primary outcome. Will use logistic regression with the randomization factors as covariates, as these factors may be associated with the study outcomes, and controlling for them is likely to increase the power to detect the between-group differences.
Measured: Up to 6 months with 3 months follow-up
Secondary outcomes (2)
Caregiver quality of life questionnaire (RAND 36-Item Health Survey)
Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate.
Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)
Measured: Up to 6 months with 3 months follow-up
Patient quality of life questionnaire
Will examine group differences over the 6-month follow-up period specifying the T4 as the primary endpoint using a dyadic model (assuming additional dependence in outcomes between patient and caregiver outcomes). This analysis will be imbedded in a linear mixed-effects (alternatively known as the multilevel) model analysis, with repeated measures over time (i.e., at end of CRT, 1-, 3- and 6-month follow-ups). In the mixed models, group will be entered as a primary variable of interest and baseline level of the outcome will be treated as a covariate.
Participants Energy/Fatigue level-(0-lowest energy level/ 100-highest energy no fatigue)
Measured: Up to 6 months with 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start28 Jan 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890834
- Sponsor's protocol ID
- 2020-0311
- Other IDs
- NCI-2020-13884, 2020-0311, R01CA247307
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthcare Utilization and Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT04890834
- Acronym / sponsor ID
- 2020-0311
- Conditions
- Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 415 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if partner-based (dyadic) yoga programs may improve the quality of life of patients with head and neck cancer undergoing chemoradiation and their caregivers, and if it is a cost-effective option. Yoga programs may decrease how often patients come to the hospital during and after treatment with chemoradiation, and improve the quality of life for both patients and caregivers.
Detailed description
PRIMARY OBJECTIVES:
- Examine the efficacy of the dyadic yoga (DY) intervention regarding reduced patient emergency department (ED) visits and feeding tube (FT) insertions and improved patient and caregiver quality of life (QOL) as compared to the usual care (UC) group.
II. Estimate intervention costs, direct medical costs, indirect costs (i.e., productivity loss), and evaluate the overall cost-effectiveness of the DY intervention for patients and caregivers.
III. Demonstrate that, compared to the UC group, the DY program improves patient and caregiver symptoms burden, objective physical function, and illness communication and reduces patient use of opioids during chemoradiotherapy (CRT), which will in turn mediate intervention outcomes at the follow-up assessments.
IV. Understand the patient and caregiver experience of head and neck cancer (HNC), healthcare utilization and symptom management and emerging themes as possible mediators as they relate to or suggest modifications of our proposed model using qualitative methods.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Patients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed.
ARM II: Patients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions.
After completion of study, participants are followed up every 2 weeks for 3 months and then monthly for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients and caregivers receive standard care including education pertaining to symptom management, prophylactic dental hygiene and possible extraction, speech pathology for baseline swallowing assessment and prophylactic treatment, and dietary services for regular nutrition consults during CRT. Psychiatry, social work, interventional radiology and supportive care services are consulted as needed. |
| Arm II (exercise, yoga sessions) | Other | Other: Best Practice, Other: Exercise Intervention, Other: Questionnaire AdministrationPatients and caregivers receive standard care as in arm I. Patients and caregivers also participate in yoga sessions 3 times per week over 60 minutes each for a total of 15 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PATIENTS: Diagnosed with a primary HNC and going to receive at least 5 weeks (25 fractions) of CRT
- PATIENTS: Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- PATIENTS: Having a family caregiver (e.g., spouse/partner, sibling, adult child) willing to participate
- PATIENTS AND CAREGIVERS: Must be at least 18 years old
- PATIENTS AND CAREGIVERS: Able to read and speak English
Key exclusion criteria (1 listed)
- PATIENTS AND CAREGIVERS: Who have regularly (self-defined) participated in a yoga program in the year prior to diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard care | Other | Arm I (Standard of care), Arm II (exercise, yoga sessions) |
| Exercise InterventionParticipate in yoga sessions | Other | Arm II (exercise, yoga sessions) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Standard of care), Arm II (exercise, yoga sessions) |
Primary outcome
Patient healthcare utilization (Standard of care)
Time frame: Up to 6 months with 3 months follow-up
Will examine group differences in patient emergency department visit (yes/no) during the observation period of during and up to 3 months post chemoradiotherapy (CRT) as the primary outcome. Will use logistic regression with the randomization factors as covariates, as these factors may be associated with the study outcomes, and controlling for them is likely to increase the power to detect the between-group differences.
2 secondary outcomes
Caregiver quality of life questionnaire (RAND 36-Item Health Survey)
Time frame: Up to 6 months with 3 months follow-up
Patient quality of life questionnaire
Time frame: Up to 6 months with 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathrin Milbury principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Exercise Intervention and Questionnaire Administration in people with Head and Neck 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 29 Sep 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?
Patient healthcare utilization (Standard of care) (time frame: Up to 6 months with 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.