Neoplasms

All Conditions

Head and Neck Neoplasms

Following the completion of baseline study measures, participants will be randomized to either do go directly into a Yoga program or to an 8 week wait-list control group. Those in the yoga program will undergo an initial Yoga Evaluation. Patients will receive customized yoga guided practice program, a home practice plan with ongoing modifications. Instructors will assess compliance. A satisfaction assessment is conducted at study-end.

Those in the wait list group will have the same assessments as those in the yoga program over the same period of time.

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.

Baseline Study Measures

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 Evaluation

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 Program

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.

Yoga Practice Plan

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

Study Assessments

Sheila H Ridner, PhD, RN

Barbara Murphy, MD

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.

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.

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

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

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

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors	NCT01951664	Head Neck Cance...	Baseline Study ... Yoga Evaluation Yoga Program Yoga Practice P... Study Assessmen...	18 Years -	Vanderbilt-Ingram Cancer Center
Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors	NCT01951664	Head Neck Cance...	Baseline Study ... Yoga Evaluation Yoga Program Yoga Practice P... Study Assessmen...	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for study assessments