A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors
Primary Purpose
Head and Neck Cancer
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Rehabilitation Education Care Program
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
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
Sites / Locations
- Shu-Ching Chen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Rehabilitation Education Care Program (RECP)
Usual care
Arm Description
Cancer rehabilitation program and patients education can improve disability and promote return to work.
Usual care
Outcomes
Primary Outcome Measures
Change barrier to return to work
Return to Work Barrier Scale (RTWBS)
Secondary Outcome Measures
Change fear of cancer progress
Fear of Progression Questionnaire (FoP-Q-SF)
Change social support
Social support/Social Support Scale (SSS)
Change quality of life
University of Washington Quality of Life Scale (UW-QOL)
Full Information
NCT ID
NCT04322695
First Posted
March 23, 2020
Last Updated
July 19, 2022
Sponsor
Chang Gung University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04322695
Brief Title
A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors
Official Title
A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors - Improve Disability and Barriers of Return to Work
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 31, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation Education Care Program (RECP)
Arm Type
Experimental
Arm Description
Cancer rehabilitation program and patients education can improve disability and promote return to work.
Arm Title
Usual care
Arm Type
Other
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Rehabilitation Education Care Program
Intervention Description
The RECP contained the following domains: (1) assessment and detection of disability; (2) home exercise; (3) activities to improve mobility; (4) dietary management; (5) patient education; and (6) vocational counseling.
Primary Outcome Measure Information:
Title
Change barrier to return to work
Description
Return to Work Barrier Scale (RTWBS)
Time Frame
3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Change fear of cancer progress
Description
Fear of Progression Questionnaire (FoP-Q-SF)
Time Frame
3 months, 6 months, and 12 months
Title
Change social support
Description
Social support/Social Support Scale (SSS)
Time Frame
3 months, 6 months, and 12 months
Title
Change quality of life
Description
University of Washington Quality of Life Scale (UW-QOL)
Time Frame
3 months, 6 months, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Shu-Ching Chen
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
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A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors
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