Clinical trial NCT04322695: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change barrier to return to work
timeFrame: 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Change fear of cancer progress
timeFrame: 3 months, 6 months, and 12 months
measure: Change social support
timeFrame: 3 months, 6 months, and 12 months
measure: Change quality of life
timeFrame: 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Shu-Ching Chen
Study officials:
References: