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A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04322695
Enrollment
120
Registered
2020-03-26
Start date
2021-07-31
Completion date
2023-07-31
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

BEHAVIORALRehabilitation Education Care Program

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.

Sponsors

Chang Gung University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Clinical diagnosis of head and neck cancer. 2. Must be age were greater than 18 years and less than 64.5 years 3. Must be able to better performance status and KPS score more than 60 4. Must be had completion of treatment more than 3 months

Exclusion criteria

1. Unemployment or retire at the time of cancer diagnosis 2. unstable systemic disease 3. Poor performance status and KPS score less than 60

Design outcomes

Primary

MeasureTime frameDescription
Change barrier to return to work3 months, 6 months, and 12 monthsReturn to Work Barrier Scale (RTWBS)

Secondary

MeasureTime frameDescription
Change fear of cancer progress3 months, 6 months, and 12 monthsFear of Progression Questionnaire (FoP-Q-SF)
Change social support3 months, 6 months, and 12 monthsSocial support/Social Support Scale (SSS)
Change quality of life3 months, 6 months, and 12 monthsUniversity of Washington Quality of Life Scale (UW-QOL)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026