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