Head and Neck CancerNCT04322695
A Rehabilitation Education Care Program on Return to Work Among Head and Neck Cancer Survivors
A study testing Rehabilitation Education Care Program in people with Head and Neck Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Rehabilitation Education Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unemployment or retire at the time of cancer diagnosis
- unstable systemic disease
- Poor performance status and KPS score less than 60
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Rehabilitation Education Care Program
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation Education Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Education Care Program (RECP) | Experimental | Cancer rehabilitation program and patients education can improve disability and promote return to work. Receives: Behavioral: Rehabilitation Education Care Program |
| Usual care | Other | Usual care Receives: Behavioral: Rehabilitation Education Care Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change barrier to return to work
Return to Work Barrier Scale (RTWBS)
Measured: 3 months, 6 months, and 12 months
Secondary outcomes (3)
Change fear of cancer progress
Fear of Progression Questionnaire (FoP-Q-SF)
Measured: 3 months, 6 months, and 12 months
Change social support
Social support/Social Support Scale (SSS)
Measured: 3 months, 6 months, and 12 months
Change quality of life
University of Washington Quality of Life Scale (UW-QOL)
Measured: 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start31 Jul 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Ching Chen, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322695
- Sponsor's protocol ID
- 201801245B0
- Status last verified
- Jul 2022
- First submitted
- 23 Mar 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang YL, Huang BS, Lin CY, Chung CF, Chen SC. Effects of a return to work program on the health and barriers to returning to work in head and neck cancer patients: A randomized controlled trial. Asia Pac J Oncol Nurs. 2023 Oct 17;10(12):100320. doi: 10.1016/j.apjon.2023.100320. eCollection 2023 Dec.
PubMed 38059206
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04322695
- Acronym / sponsor ID
- 201801245B0
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Education Care Program (RECP) | Experimental | Behavioral: Rehabilitation Education Care ProgramCancer rehabilitation program and patients education can improve disability and promote return to work. |
| Usual care | Other | Behavioral: Rehabilitation Education Care ProgramUsual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unemployment or retire at the time of cancer diagnosis
- unstable systemic disease
- Poor performance status and KPS score less than 60
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation Education Care ProgramThe 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. | Behavioural | Rehabilitation Education Care Program (RECP), Usual care |
Primary outcome
Change barrier to return to work
Time frame: 3 months, 6 months, and 12 months
Return to Work Barrier Scale (RTWBS)
3 secondary outcomes
Change fear of cancer progress
Time frame: 3 months, 6 months, and 12 months
Change social support
Time frame: 3 months, 6 months, and 12 months
Change quality of life
Time frame: 3 months, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38059206Chang YL, Huang BS, Lin CY, Chung CF, Chen SC. Effects of a return to work program on the health and barriers to returning to work in head and neck cancer patients: A randomized controlled trial. Asia Pac J Oncol Nurs. 2023 Oct 17;10(12):100320. doi: 10.1016/j.apjon.2023.100320. eCollection 2023 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Education Care Program in people with Head and Neck Cancer, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change barrier to return to work (time frame: 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.