Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

Study Overview
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Brief Summary
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This is a randomized prospective pilot study assessing the safety and feasibility of two yoga interventions in head and neck cancer patients undergoing primary or adjuvant radiation with or without concurrent chemotherapy

Detailed Description
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Primary Objective: - To assess the safety and feasibility of Hatha yoga in head and neck cancer patients undergoing treatment with primary or adjuvant radiation with or without chemotherapy.

Official Title
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Feasibility Study of a Yoga Intervention in Head and Neck Cancer Patients Undergoing Concurrent Chemo-Radiation

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Behavioral: Yoga Video
* Behavioral: Posture and Strengthening Video
* Behavioral: Relaxation Video
* Behavioral: Breath Work Video
* Behavioral: Satisfaction Survey
* Behavioral: Guided Yoga Session
* Behavioral: Written Yoga Instructions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Locally advanced, non-metastatic, histologically confirmed malignancy involving the head and neck region o Larynx, pharynx, oral cavity, salivary gland, paranasal sinuses and unknown primary Age greater or equal to 21 years of age Planned for either definitive or adjuvant radiation therapy with or without chemotherapy o Patients may have received induction chemotherapy or primary surgical resection prior to proceeding to radiation therapy Ability to understand English Daily access to the internet Willing and able to sign informed consent Willing and able to participate in yoga sessions as outlined in the study protocol Exclusion criteria: Prior head and neck cancer radiation Patients who in the opinion of the treating physician are physically, medically or psychologically impaired to the point that participation is not deemed appropriate or feasible

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video and Written Yoga Instruction<br>Videos and written instructions on Hatha yoga will be provided | Behavioral: Yoga Video<br>* A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.<br>Behavioral: Posture and Strengthening Video<br>* The strengthening video directs patients through a sequence of isometric exercises to strengthen neck, shoulder and core muscles that are critical for good posture and musculoskeletal integrity. The patient may opt to do the strengthening exercises standing, sitting or with their back on the floor depending on their strength. The video lasts 20 minutes.<br>Behavioral: Relaxation Video<br>* The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes<br>Behavioral: Breath Work Video<br>* The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.<br>Behavioral: Satisfaction Survey<br>* Participants will complete a questionnaire addressing satisfaction with the yoga program.<br>Behavioral: Written Yoga Instructions<br>* Introduction to Yoga and Yoga poses<br>|
| Experimental: Video, Written Yoga Instruction Plus Guided Yoga Sessions<br>Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided | Behavioral: Yoga Video<br>* A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.<br>Behavioral: Posture and Strengthening Video<br>* The strengthening video directs patients through a sequence of isometric exercises to strengthen neck, shoulder and core muscles that are critical for good posture and musculoskeletal integrity. The patient may opt to do the strengthening exercises standing, sitting or with their back on the floor depending on their strength. The video lasts 20 minutes.<br>Behavioral: Relaxation Video<br>* The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes<br>Behavioral: Breath Work Video<br>* The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.<br>Behavioral: Satisfaction Survey<br>* Participants will complete a questionnaire addressing satisfaction with the yoga program.<br>Behavioral: Guided Yoga Session<br>* Instructor guided yoga session twice a week<br>Behavioral: Written Yoga Instructions<br>* Introduction to Yoga and Yoga poses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Hatha yoga | Number of adverse events as graded by CTCAE 4.0 | Approximately 8 weeks | 
| Feasibility of Hatha yoga | At least 50% of patients will need to moderately compliant to be feasible (Compliance will be defined as:Fully Compliant: Participation in at least 1 yoga activity on at least 70% of days on study; Moderately Compliant: Participation in at least 1 yoga activity on at least 40% of days on study;Noncompliant: Participation on less than 40% of days on study) | Approximately 8 weeks |