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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01951664
First received: September 23, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention
Head Neck Cancer
Other: Baseline Study Measures
Behavioral: Yoga Evaluation
Behavioral: Yoga Program
Behavioral: Yoga Practice Plan
Other: Study Assessments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Number of patients who complete a modified Yoga program for HNC survivors [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in range of motion (ROM) jaw maximal inter-incisoral opening [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    Change in ROM from baseline in the jaw maximal inter-incisoral opening, measured in millimeters (mm)

  • Change in cervical ROM [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in cervical ROM, measured in degrees of neck movement

  • Change in head and neck-related treatment systems [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    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 in Brief Pain Inventory [ Time Frame: at 8 weeks ] [ Designated as safety issue: Yes ]
    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 in Body Image Quality of Life Inventory [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
    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 in Anxiety and Depression Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in scores on the Hospital Anxiety and Depression Inventory with a score of >/= 8 as possible cause for mental health referral


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951664

Contacts
Contact: Vanderbilt Cancer Center Clinical Trials Information Program 800-811-8480
Contact: Melissa Adair, AD, RN 615-343-6313 Melissa.A.Adair@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University School of Nursing Recruiting
Nashville, Tennessee, United States, 37232
Contact: Melissa A Adair, AD, RN    615-343-6313    melissa.a.adair@vanderbilt.edu   
Principal Investigator: Sheila H Ridner, PhD, RN         
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt Cancer Center Clinical Trials Information Program    800-811-8480      
Principal Investigator: Barbara Murphy, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
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:
No publications provided

Responsible Party: Sheila Ridner, Martha Rivers Ingram Professor of Nursing, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01951664     History of Changes
Other Study ID Numbers: VICC SUPP 1282, 1R21CA173202-01
Study First Received: September 23, 2013
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 21, 2014