Feasibility and Preliminary Efficacy of Hatha Yoga in Head and Neck Cancer Survivors
- Conditions
- Head Neck Cancer
- Interventions
- Other: Baseline Study MeasuresBehavioral: Yoga EvaluationBehavioral: Yoga ProgramBehavioral: Yoga Practice PlanOther: Study Assessments
- Registration Number
- NCT01951664
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- >/= 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified Yoga Program for HNC Survivors Yoga Practice Plan 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. Modified Yoga Program for HNC Survivors Yoga Evaluation 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. Modified Yoga Program for HNC Survivors Study Assessments 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. Modified Yoga Program for HNC Survivors Yoga Program 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. Wait list control Baseline Study Measures Those in the wait list group will have the same assessments as those in the yoga program over the same period of time. Modified Yoga Program for HNC Survivors Baseline Study Measures 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. Wait list control Study Assessments Those in the wait list group will have the same assessments as those in the yoga program over the same period of time.
- Primary Outcome Measures
Name Time Method Number of patients who complete a modified Yoga program for HNC survivors 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
- Secondary Outcome Measures
Name Time Method Change in cervical ROM at 8 weeks Change from baseline in cervical ROM, measured in degrees of neck movement
Change in head and neck-related treatment systems 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 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 Anxiety and Depression Scale 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
Change in Body Image Quality of Life Inventory 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 range of motion (ROM) jaw maximal inter-incisoral opening at 8 weeks Change in ROM from baseline in the jaw maximal inter-incisoral opening, measured in millimeters (mm)
Trial Locations
- Locations (2)
Vanderbilt University School of Nursing
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States