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Clinical Trials/NCT04322695
NCT04322695
Unknown
N/A

A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors - Improve Disability and Barriers of Return to Work

Chang Gung University of Science and Technology1 site in 1 country120 target enrollmentJuly 31, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Chang Gung University of Science and Technology
Enrollment
120
Locations
1
Primary Endpoint
Change barrier to return to work
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study will to identify factors (performance ability, physical function, psychosocial function, fear of cancer progression, social support, demographic characteristics, and disease-related characteristics) that impact the Return to work and work status in survivors of HNC within one year after completion treatment. Head and neck cancer survivors who have attended a rehabilitation education care program (RECP) intervention will have better performance ability, physical function, psychosocial function, fear of cancer progress, social support, and lower return to work to patients who not attended with the intervention.

Detailed Description

The purpose of this 2-year project will involve a randomized controlled clinical trial to evaluate the 3-months RECP. Eligible participants will be recruited from initial completion treatment to 6 months after completion treatment and randomized into a control group and an experimental group, with the control group patients receiving routine hospital care and the experimental group patients receiving the 3-months RECP. Outcomes will be assessed using Return to Work Barrier Scale (RTWBS), Fear of Progression Questionnaire (FoP-Q-SF), Social Support Scale (SSS), University of Washington Quality of Life Scale (UW-QOL), Karnofsky's Performance Score (KPS), Katz Activities of Daily Living Scale (ADL), and Instrument Activities of Daily Living Scale (IADL). Subjective data will be collected at four time points: baseline (6 months after completion of treatment)(T0) and then 9, 12, and 18months after completion of treatment (T1, T2, and T3, respectively). Objective data will be assessed at the same time points. The mixed-model repeated measure ANOVA will be used to analyze the data. The investigators plan to recruit 30 subjects for each group.

Registry
clinicaltrials.gov
Start Date
July 31, 2021
End Date
July 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shu-Ching Chen

Professor

Chang Gung University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of head and neck cancer.
  • Must be age were greater than 18 years and less than 64.5 years
  • Must be able to better performance status and KPS score more than 60
  • Must be had completion of treatment more than 3 months

Exclusion Criteria

  • Unemployment or retire at the time of cancer diagnosis
  • unstable systemic disease
  • Poor performance status and KPS score less than 60

Outcomes

Primary Outcomes

Change barrier to return to work

Time Frame: 3 months, 6 months, and 12 months

Return to Work Barrier Scale (RTWBS)

Secondary Outcomes

  • Change quality of life(3 months, 6 months, and 12 months)
  • Change fear of cancer progress(3 months, 6 months, and 12 months)
  • Change social support(3 months, 6 months, and 12 months)

Study Sites (1)

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