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

NCT01951664 | Completed

• 2 other identifiers: VICC SUPP 12821R21CA173202-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients who complete a modified Yoga program for HNC 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

  at 8 weeks

Secondary Outcomes (6)

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

  at 8 weeks

• Change in cervical ROM

  at 8 weeks

• Change in head and neck-related treatment systems

  at 8 weeks

• Change in Brief Pain Inventory

  at 8 weeks

• Change in Body Image Quality of Life Inventory

  at 8 weeks

Study Arms (2)

Modified Yoga Program for HNC Survivors

EXPERIMENTAL

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; Behavioral: Yoga Evaluation; Behavioral: Yoga Program; Behavioral: Yoga Practice Plan; Other: Study Assessments

Wait list control

ACTIVE COMPARATOR

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; Other: Study Assessments

Interventions

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.

Modified Yoga Program for HNC Survivors; Wait list control

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

Modified Yoga Program for HNC Survivors

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

Modified Yoga Program for HNC Survivors

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.

Modified Yoga Program for HNC Survivors

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

Modified Yoga Program for HNC Survivors; Wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37232, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sheila H Ridner, PhD, RN

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Martha Rivers Ingram Professor of Nursing

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 27, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

US (2)