AzTrials
AzTrials

Head Neck CancerNCT01951664

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

A study testing Baseline Study Measures, Yoga Evaluation and Yoga Program in people with Head Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head Neck Cancer
What is being tested?
Baseline Study Measures, Yoga Evaluation and Yoga Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
Aug 2013to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >/= 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
Show all 9Show fewer
  • willing and able to provide informed consent
  • completed medically indicated physical therapy
  • medical clearance by study medical oncologist

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Vanderbilt University School of Nursing

    Nashville, Tennessee, 37232

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

Read the 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.

Being tested
Baseline Study Measures, Yoga Evaluation, Yoga Program, Yoga Practice Plan, Study Assessments
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Baseline Study MeasuresOther

    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.

  • Yoga EvaluationBehavioural

    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 ProgramBehavioural

    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 PlanBehavioural

    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.

  • Study AssessmentsOther

    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

Study groups in NCT01951664
Study groupRoleWhat they receive
Modified Yoga Program for HNC SurvivorsExperimentalFollowing 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.
Receives: Other: Baseline Study Measures; Behavioral: Yoga Evaluation; Behavioral: Yoga Program; Behavioral: Yoga Practice Plan; Other: Study Assessments
Wait list controlActive comparatorThose in the wait list group will have the same assessments as those in the yoga program over the same period of time.
Receives: Other: Baseline Study Measures; Other: Study Assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at 8 weeks

Secondary outcomes (6)

  1. 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)

    Measured: at 8 weeks

  2. Change in cervical ROM

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

    Measured: at 8 weeks

  3. 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

    Measured: at 8 weeks

  4. 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

    Measured: at 8 weeks

  5. 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

    Measured: at 8 weeks

  6. 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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01951664
Sponsor's protocol ID
VICC SUPP 1282
Other IDs
1R21CA173202-01
Status last verified
Apr 2016
First submitted
23 Sep 2013
Last updated
27 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Baseline Study Measures, Yoga Evaluation and Yoga Program in people with Head Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who complete a modified Yoga program for HNC survivors (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01951664.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in