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

Primary Purpose

Head Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Baseline Study Measures

Yoga Evaluation

Yoga Program

Yoga Practice Plan

Study Assessments

About this trial

This is an interventional supportive care trial for Head Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Vanderbilt University School of Nursing
Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Yoga Program for HNC Survivors

Wait list control

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Change in cervical ROM

Change from baseline in cervical ROM, measured in degrees of neck movement

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

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

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

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

Full Information

NCT ID

NCT01951664

First Posted

September 23, 2013

Last Updated

April 26, 2016

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01951664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Neck Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified Yoga Program for HNC Survivors

Arm Type

Experimental

Arm Description

Arm Title

Wait list control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Baseline Study Measures

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Yoga Evaluation

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Yoga Program

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Yoga Practice Plan

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Study Assessments

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

at 8 weeks

Secondary Outcome Measure Information:

Title

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

Description

Change in ROM from baseline in the jaw maximal inter-incisoral opening, measured in millimeters (mm)

Time Frame

at 8 weeks

Title

Change in cervical ROM

Description

Change from baseline in cervical ROM, measured in degrees of neck movement

Time Frame

at 8 weeks

Title

Change in head and neck-related treatment systems

Description

Time Frame

at 8 weeks

Title

Change in Brief Pain Inventory

Description

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

Time Frame

at 8 weeks

Title

Change in Body Image Quality of Life Inventory

Description

Time Frame

at 8 weeks

Title

Change in Anxiety and Depression Scale

Description

Change from baseline in scores on the Hospital Anxiety and Depression Inventory with a score of >/= 8 as possible cause for mental health referral

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila H Ridner, PhD, RN

Organizational Affiliation

Vanderbilt University School of Nursing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Barbara Murphy, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University School of Nursing

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.vicc.org/ct/

Description

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

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

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