Rehabilitation Outcomes in Head and Neck Survivors

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Tongue neoplasm
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Brief Title

Rehabilitation Outcomes in Head and Neck Survivors

Official Title

Rehabilitation Outcomes in Head and Neck Survivors

Brief Summary

      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.

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

Primary Outcome

return to work as measured by interview

Secondary Outcome

 shoulder function measured by function-related tests

Condition

Head and Neck Cancer

Intervention

Physiotherapy

Study Arms / Comparison Groups

 initial
Description:  0 month begin physiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

65

Start Date

January 1, 2015

Completion Date

June 30, 2016

Primary Completion Date

June 30, 2016

Eligibility Criteria

        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

Gender

All

Ages

20 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Yueh-Hsia Chen, Master, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT03206242

Organization ID

104-2300C

Secondary IDs

CGMH-IRB-103-5164B

Responsible Party

Sponsor

Study Sponsor

Chang Gung Memorial Hospital

Study Sponsor

Yueh-Hsia Chen, Master, Principal Investigator, Chang Gung Memorial Hospital

Verification Date

May 2015