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

• ClinicalTrials.gov Identifier: NCT01951664
• Recruitment Status: Completed
• First Posted: September 27, 2013
• Last Update Posted: April 27, 2016
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Institutes of Health (NIH); National Cancer Institute (NCI)
• Information provided by (Responsible Party): Sheila Ridner, Vanderbilt-Ingram Cancer Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Head Neck Cancer	Other: Baseline Study Measures; Behavioral: Yoga Evaluation; Behavioral: Yoga Program; Behavioral: Yoga Practice Plan; Other: Study Assessments	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
• Study Start Date: August 2013
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Modified Yoga Program for HNC Survivors; 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.	Other: Baseline Study Measures; 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.; Behavioral: Yoga Evaluation; 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; Behavioral: Yoga Program; 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; Behavioral: Yoga Practice Plan; 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.; Other: Study Assessments; 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
Active Comparator: Wait list control; Those in the wait list group will have the same assessments as those in the yoga program over the same period of time.	Other: Baseline Study Measures; 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.; Other: Study Assessments; 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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University School of Nursing

Nashville, Tennessee, United States, 37232

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sheila H Ridner, PhD, RN; Vanderbilt University School of Nursing
• Principal Investigator: Barbara Murphy, MD; Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial 

• Responsible Party: Sheila Ridner, Martha Rivers Ingram Professor of Nursing, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT01951664
• Other Study ID Numbers: VICC SUPP 1282; 1R21CA173202-01 ( U.S. NIH Grant/Contract )
• First Posted: September 27, 2013
• Last Update Posted: April 27, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms