Clinical trial NCT03206242: Rehabilitation Outcomes in Head and Neck Survivors
Official title: Rehabilitation Outcomes in Head and Neck Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Oral Cancer
Keywords: Rehabilitation
Physiotherapy
Trismus
Pain
Return to work
Quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receive physical therapy at Linkou Chang Gung Memorial Hospital will be invited to participate this study.

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.

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

Primary outcomes:
measure: return to work as measured by interview
timeFrame: 1 year
measure: quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30
timeFrame: 1 year
measure: physical functions measured by 6-minute walking test
timeFrame: 1 year
measure: quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35
timeFrame: 1 year
measure: physical functions measured by time up & go test
timeFrame: 1 year
Secondary outcomes:
measure: shoulder function measured by function-related tests
timeFrame: 1 year
measure: pain measured by Visual Analog Scale
timeFrame: 1 year
measure: mouth opening measured by Boley gauge
timeFrame: 1 year
measure: joint range of motion measured by goniometer
timeFrame: 1 year
measure: muscle strength measured by manual muscle testing
timeFrame: 1 year
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Plastic and Reconstructive Surgery Rehabilitation Center, Chung Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yueh-Hsia Chen, Master
role: PRINCIPAL_INVESTIGATOR
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