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

Vanderbilt University Medical Center

Status

Completed

Conditions

Head Neck Cancer

Treatments

Behavioral: Yoga Program

Behavioral: Yoga Practice Plan

Other: Study Assessments

Behavioral: Yoga Evaluation

Other: Baseline Study Measures

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01951664

VICC SUPP 1282

1R21CA173202-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Modified Yoga Program for HNC Survivors

Experimental group

Description:

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.

Treatment:

Other: Study Assessments

Behavioral: Yoga Evaluation

Other: Baseline Study Measures

Behavioral: Yoga Practice Plan

Behavioral: Yoga Program

Wait list control

Active Comparator group

Description:

Those in the wait list group will have the same assessments as those in the yoga program over the same period of time.

Treatment:

Other: Study Assessments