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

NCT ID: NCT04146779

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-10-06

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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Video and Written Yoga Instruction

Videos and written instructions on Hatha yoga will be provided

Group Type EXPERIMENTAL

Yoga Video

Intervention Type BEHAVIORAL

A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Posture and Strengthening Video

Intervention Type BEHAVIORAL

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.

Relaxation Video

Intervention Type BEHAVIORAL

The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Breath Work Video

Intervention Type BEHAVIORAL

The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Satisfaction Survey

Intervention Type BEHAVIORAL

Participants will complete a questionnaire addressing satisfaction with the yoga program.

Written Yoga Instructions

Intervention Type BEHAVIORAL

Introduction to Yoga and Yoga poses

Video, Written Yoga Instruction Plus Guided Yoga Sessions

Videos and written instructions on Hatha yoga and instructor guided session on Hatha yoga will be provided

Group Type EXPERIMENTAL

Yoga Video

Intervention Type BEHAVIORAL

A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Posture and Strengthening Video

Intervention Type BEHAVIORAL

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.

Relaxation Video

Intervention Type BEHAVIORAL

The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Breath Work Video

Intervention Type BEHAVIORAL

The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Satisfaction Survey

Intervention Type BEHAVIORAL

Participants will complete a questionnaire addressing satisfaction with the yoga program.

Guided Yoga Session

Intervention Type BEHAVIORAL

Instructor guided yoga session twice a week

Written Yoga Instructions

Intervention Type BEHAVIORAL

Introduction to Yoga and Yoga poses

Interventions

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Yoga Video

A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.

Intervention Type BEHAVIORAL

Posture and Strengthening Video

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.

Intervention Type BEHAVIORAL

Relaxation Video

The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes

Intervention Type BEHAVIORAL

Breath Work Video

The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.

Intervention Type BEHAVIORAL

Satisfaction Survey

Participants will complete a questionnaire addressing satisfaction with the yoga program.

Intervention Type BEHAVIORAL

Guided Yoga Session

Instructor guided yoga session twice a week

Intervention Type BEHAVIORAL

Written Yoga Instructions

Introduction to Yoga and Yoga poses

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Murphy, MD

Sponsor Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VICC SUPP 18154

Identifier Type: -

Identifier Source: org_study_id

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