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Rehabilitation Outcomes in Head and Neck Survivors (HNC)

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ClinicalTrials.gov Identifier: NCT03206242
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date February 17, 2015
First Posted Date July 2, 2017
Last Update Posted Date July 2, 2017
Actual Study Start Date January 1, 2015
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2017)
  • return to work as measured by interview [ Time Frame: 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 ]
  • physical functions measured by 6-minute walking test [ Time Frame: 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 ]
  • physical functions measured by time up & go test [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 30, 2017)
  • shoulder function measured by function-related tests [ Time Frame: 1 year ]
  • pain measured by Visual Analog Scale [ Time Frame: 1 year ]
  • mouth opening measured by Boley gauge [ Time Frame: 1 year ]
  • joint range of motion measured by goniometer [ Time Frame: 1 year ]
  • muscle strength measured by manual muscle testing [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects receive physical therapy at Linkou Chang Gung Memorial Hospital will be invited to participate this study.
Condition
  • Head and Neck Cancer
  • Oral Cancer
Intervention 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 Name: Rehabilitation
Study Groups/Cohorts
  • initial
    0 month begin physiotherapy
    Intervention: Other: Physiotherapy
  • 3 months after physiotherapy
    3 months after physiotherapy
    Intervention: Other: Physiotherapy
  • 6 months after physiotherapy
    6 months after physiotherapy
    Intervention: Other: Physiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 30, 2017)
65
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2016
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03206242
Other Study ID Numbers 104-2300C
CGMH-IRB-103-5164B ( Registry Identifier: CGMH )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Yueh-Hsia Chen, Master Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date May 2015