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

Head Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951664
• Other study ID #: VICC SUPP 1282
• Secondary ID: 1R21CA173202-01
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: April 26, 2016
• Start date: August 2013
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head Neck Cancer

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University School of Nursing	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in range of motion (ROM) jaw maximal inter-incisoral opening	Change in ROM from baseline in the jaw maximal inter-incisoral opening, measured in millimeters (mm)	at 8 weeks	No
Secondary	Change in cervical ROM	Change from baseline in cervical ROM, measured in degrees of neck movement	at 8 weeks	No
Secondary	Change in head and neck-related treatment systems	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	at 8 weeks	No
Secondary	Change in Brief Pain Inventory	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	at 8 weeks	Yes
Secondary	Change in Body Image Quality of Life Inventory	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	at 8 weeks	No
Secondary	Change in Anxiety and Depression Scale	Change from baseline in scores on the Hospital Anxiety and Depression Inventory with a score of >/= 8 as possible cause for mental health referral	8 weeks	No

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial