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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


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
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