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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951664
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : April 27, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sheila Ridner, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date  ICMJE September 23, 2013
First Posted Date  ICMJE September 27, 2013
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
  • 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)
  • Change in cervical ROM [ Time Frame: at 8 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    Change from baseline in scores on the Hospital Anxiety and Depression Inventory with a score of >/= 8 as possible cause for mental health referral
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
Official Title  ICMJE Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head Neck Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Baseline Study Measures
    • Behavioral: Yoga Evaluation
    • Behavioral: Yoga Program
    • Behavioral: Yoga Practice Plan
    • Other: Study Assessments
  • 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.
    Interventions:
    • Other: Baseline Study Measures
    • Other: Study Assessments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2013)
30
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951664
Other Study ID Numbers  ICMJE VICC SUPP 1282
1R21CA173202-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheila Ridner, Vanderbilt-Ingram Cancer Center
Study Sponsor  ICMJE Vanderbilt-Ingram Cancer Center
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sheila H Ridner, PhD, RN Vanderbilt University School of Nursing
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP