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NCT Number: NCT01951664

Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors

Treatment for head and neck cancer can result in marked musculo-skeletal impairment (MSI). This study will examine the effects of Hatha Yoga as a therapeutic modality to address MSI.

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Key information

Conditions

Head Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University School of Nursing, Nashville, Tennessee, United States

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About this study

The use of aggressive treatment for head and neck cancer (HNC) particularly combined modality treatment regimens has resulted in an increase in survival. Unfortunately, this improvement has come with a marked increase in acute and late-effects. Acute HNC treatment-related toxicities have been clearly and extensively documented; however, data pertaining to adverse late-effects, those most likely to impact the survivor's long term symptom burden, functionality, and overall quality of life (QOL), are limited. This pilot study will be conducted to examine the feasibility of tailored Hatha Yoga as a therapeutic modality to address MSI in patients who have survived HNC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >/= 18 years of age
  • >3 months post-treatment of HNC
  • no active cancer
  • ability to understand English in order to complete questionnaires
  • willing to participate in the guided and home Yoga practice
  • willing to drive to the study site
  • willing and able to provide informed consent
  • completed medically indicated physical therapy
  • medical clearance by study medical oncologist

Exclusion criteria

  • a prior cancer diagnosis within the past three years (except basal cell, surgically treated squamous cell skin cancer, early prostate cancer under observation)
  • have received radiation therapy or chemotherapy for any condition other than primary HNC
  • medical conditions that would prohibit the safe implementation of a Yoga practice (e.g., vertigo, dementia)
  • active Yoga practice within the past 6 months

Treatment and study plan

Baseline Study Measures

Other

Participants will undergo baseline objective and self-report study measures including: 1) ROM in the jaw, neck, and shoulders; 2) posture assessment; 3) pain, and 4) psychological distress. The study measures will take 30-45 minutes to administer.

Yoga Evaluation

Behavioral

The evaluation includes an assessment of nine traditional Yoga components: energy, symptoms, emotions, posture, breathing patterns, gait, muscle/tissue quality, joint flexibility, and muscle strength. Emphasis will be placed on the assessment of jaw/neck/shoulder MSI requiring Yoga practice modification of those poses that are unsafe or not feasible for a patient to perform. Information from the evaluation will be used to establish the tailored Yoga program

Yoga Program

Behavioral

The Yoga program has 5 components: 1) Awareness Practice to enhance self-awareness, 2)Poses - 16 core poses will be modified for each patient's specific needs, 3)Breath Work - breath awareness and proper breathing for maximum benefit, 4)Relaxation - alternating between methods of relaxation, 5)Mediation - awareness and practice of inner silence

Yoga Practice Plan

Behavioral

To enhance fidelity, a standardized Yoga intervention was chosen that includes postures, meditation, relaxation, and breath work. To ensure safety, the practice plan for each patient will be reviewed prior to initiation. All MSI limitations will be discussed, and appropriate adaptive techniques will be formulated. Qualitative techniques will be used to describe and categorize the types of impairment and modifications. By developing a catalog of impairments and suitable modifications, a safe and uniform Yoga program can be further tested and widely disseminated.

Study assessments

Other

Data collection methods used to assess efficacy include physical measurement/examination, jaw range of motion (device) - scales to measure opening, cervical range of motion(Device), Shoulder Range of Motion - Goniometer, Posture - Wall Zone Grid, self-reported surveys for physical symptoms, pain, psychological symptoms, anxiety, depression and quality of life

Primary outcomes

  1. Number of patients who complete a modified Yoga program for HNC survivors

    Time frame: at 8 weeks

    Number of patients that complete an 8-week course of guided yoga sessions and that complete a Participant Practice Log to document their non-guided home yoga sessions

Secondary outcomes

  1. Change in range of motion (ROM) jaw maximal inter-incisoral opening

    Time frame: at 8 weeks

    Change in ROM from baseline in the jaw maximal inter-incisoral opening, measured in millimeters (mm)

  2. Change in cervical ROM

    Time frame: at 8 weeks

    Change from baseline in cervical ROM, measured in degrees of neck movement

  3. Change in head and neck-related treatment systems

    Time frame: at 8 weeks

    Change from baseline in the Vanderbilt Head and Neck Symptom Survey: 9 questions on treatment-related symptoms with 0 = least amount of problems to 10 = most amount of problems. Higher scores indicate increased treatment-related distress

  4. Change in Brief Pain Inventory

    Time frame: at 8 weeks

    Change from baseline in scores for the Brief Pain Inventory: 9 items with 0 = no pain to 10 = pain as bad as you can imagine. Higher sum of scores indicate greater pain burden

  5. Change in Body Image Quality of Life Inventory

    Time frame: at 8 weeks

    Change from baseline in scores in the Change in Body Image Quality of Life Inventory. 18 questions with minus 3 = very negative effect to plus 3 = very positive effect. sum of scores with higher scores indicating a more positive body image

  6. Change in Anxiety and Depression Scale

    Time frame: 8 weeks

    Change from baseline in scores on the Hospital Anxiety and Depression Inventory with a score of >/= 8 as possible cause for mental health referral

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2013
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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