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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Rehabilitation Education Care Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Shu-Ching Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care	Behavioral: Rehabilitation 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.
Experimental: Rehabilitation Education Care Program (RECP); Cancer rehabilitation program and patients education can improve disability and promote return to work.	Behavioral: Rehabilitation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change barrier to return to work	Return to Work Barrier Scale (RTWBS)	3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change fear of cancer progress	Fear of Progression Questionnaire (FoP-Q-SF)	3 months, 6 months, and 12 months
Change social support	Social support/Social Support Scale (SSS)	3 months, 6 months, and 12 months
Change quality of life	University of Washington Quality of Life Scale (UW-QOL)	3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 201801245B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No