Rehabilitation Outcomes in Head and Neck Survivors (HNC)

June 30, 2017 updated by: Chang Gung Memorial Hospital

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Advanced treatments make survival rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. Physical therapy may have benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and oral structures coordination. Return to work in the number of cancer survivors is a realistic outcome. Rehabilitation effects on functional restorations and quality of life for head and neck survivors are needed for further studied.

The purpose of this project is to explore the rehabilitation effects following head and neck reconstructive survivors. The investigators measure temporomandibular joint function, shoulder function, pain monthly. Physical functions, self-reported quality of life, and the status of return to work are measured 3 and 6 months after surgery. This prospective study could help to predict the rehabilitation outcomes and benefits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Oral functions include respiration, speech, mastication, deglutition, and cosmetics. Advanced treatments make survival rates increased, but might develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. The purpose of this project is to explore the effects of rehabilitation following reconstructive surgery in oral cancer survivors.

This study design is an interrupted time-series design. The investigators will recruit 50 subjects one week following reconstructive surgery. The measurements include manual muscle strength, joint range of motion, maximal mouth opening, pain status, hand-to-neck test, hand-to-scapula test, hand-to-opposite-scapula test, 6-minute walking test, timed up & go test, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35 and return-to-work. These tests were done at the first visit (0 week post-operation), three months and six months after reconstructive surgery respectively. The intervention programs consist of edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training. Continuous variables were analyzed by descriptive statistics. One-way ANOVA was used to compare the difference between measurements. Binary logistic regression was used to predict the factors of return-to-work.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects receive physical therapy at Linkou Chang Gung Memorial Hospital will be invited to participate this study.

Description

Inclusion Criteria:

  • Clinical diagnosis of oral cancer
  • Post-reconstructive surgery
  • Age between 20 to 65 years old
  • Must be able to follow instructions

Exclusion Criteria:

  • Central nervous disease
  • Metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
initial
0 month begin physiotherapy
Other: Physiotherapy
Interventions of physical therapy will be implemented after reconstructive surgery including edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training.
Other Names:
  • Rehabilitation
3 months after physiotherapy
Other: Physiotherapy
Interventions of physical therapy will be implemented after reconstructive surgery including edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training.
Other Names:
  • Rehabilitation
6 months after physiotherapy
Other: Physiotherapy
Interventions of physical therapy will be implemented after reconstructive surgery including edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training.
Other Names:
  • Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
return to work as measured by interview
Time Frame: 1 year
1 year
quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
Time Frame: 1 year
1 year
physical functions measured by 6-minute walking test
Time Frame: 1 year
1 year
quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
Time Frame: 1 year
1 year
physical functions measured by time up & go test
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
shoulder function measured by function-related tests
Time Frame: 1 year
1 year
pain measured by Visual Analog Scale
Time Frame: 1 year
1 year
mouth opening measured by Boley gauge
Time Frame: 1 year
1 year
joint range of motion measured by goniometer
Time Frame: 1 year
1 year
muscle strength measured by manual muscle testing
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

June 30, 2016

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

June 30, 2017

First Posted (ACTUAL)

July 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-2300C
  • CGMH-IRB-103-5164B (REGISTRY: CGMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Physiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe