Head and Neck CancerNCT06756763
Head and Neck Quality of Life
An observational study of Head and Neck Cancer and Free Flap, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study examines the quality of life for patients after head and neck free flap reconstruction, both pre-operative and at least 1 year post-operative. It aims to find out what influences quality of life, and whether these changes are stable over time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer, Free Flap
- How many people
- 315 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2015to 26 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Head and neck disease both benign and maligant
Who may be able to join
- free flap reconstruction
- benign or malignant head and neck disease
Who cannot join
- did not undergo free flap reconstruction
- extra-oral disease eg scalp
- patients unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life After Head and Neck Free Flap Reconstruction: a Prospective Time to Deterioration Analysis
This study examines the quality of life for patients after head and neck free flap reconstruction, both pre-operative and at least 1 year post-operative. It aims to find out what influences quality of life, and whether these changes are stable over time. It will use a new method of analysis called "Time to Deterioration" which tells us when a patient notices a significant change in their quality of life, when subsequently does not get better.
Read the detailed description
Methods
Prospectively collected quality of life (QoL) study using a longitudinal TTD approach in a large cohort of head and neck free flap reconstruction patients. Questionnaires completed pre-operatively and at outpatient clinic visits, with concomitant examination and complication status recorded. Quality of life data collected by a clinician not involved in the research.
Participants and Setting Participants recruited from Chang Gung Memorial Hospital, Linkou, Taiwan. Inclusion criteria included all patients undergoing free flap reconstruction of benign or malignant head and neck disease, who had completed both pre-operative and a minimum of one post-operative questionnaire, at least 1 year post-operatively. Exclusion criteria included patients that did not undergo free flap reconstruction, extra-oral disease eg scalp, no pre-operative questionnaire, post-operative questionnaire without at least 1 year follow up, and patients unable to consent.
Primary outcome University of Winconsin Quality of Life (UW-QoL) questionnaire (Taiwan mandarin version v4) is a 12-item scale with additional global questions, scored from 0 to 100, with separate Physical and Social component scores providing a composite overall score.
Quality of Life primary outcomes Separate analysis of component scores, rather than overall score, is suggested in UW-QoL scoring guidelines. This study examined Physical component score as the primary outcome.
Missing data Missing data in UW QoL questionairres were handled according to published scoring guidelines, with a minimum 4 components in both physical and social subscores.
Time to Deterioration (TTD) definitions TTD methodology was used to assess changes in QoL over time. TTD is defined as a drop of > 5 points in QoL scores without a subsequent increase > 5 points compared to the previous score. Comparison with previous score accounts for 'response shift' in patient perceptions, whereby patients get accustomed to a new normal by internal recalibration. QoL studies typically use a General Linear Mixed Model approach that does not quantify for this 'response shift'. Using this approach also better accounts for 'reversibility' in QoL . Previous score was used rather than previous best score. An MCID of 5 points has been proposed for TTD methodology which is in line with estimates of 5-10% in the the UW QoL scoring guidelines.
Health Related Quality of Life (HRQoL) Deterioration Free Survival HRQoL deterioration free survival includes death (all cause death) as an event and is akin to overall survival.
- Conditions
- Head and Neck Cancer, Free Flap
- Keywords
- Quality of life, Longitudinal, Survival
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Head and Neck Reconstruction patients | Head and Neck Reconstruction patients undergoing free flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of Wisconsin Quality of Life Questionnaire
University of Winconsin Quality of Life (UW-QoL) questionnaire (Taiwan mandarin version v4) is a 12-item scale with additional global questions, scored from 0 to 100, with separate Physical and Social component scores providing a composite overall score. Higher scores indicate higher quality of life.
Measured: Once at enrollment pre-operatively, and repeated at least 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Mar 2015
- Primary completion1 Sep 2023
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756763
- Sponsor's protocol ID
- 201402788B0
- Status last verified
- Dec 2024
- First submitted
- 27 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD shared on reasonable request to the authors
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Head and Neck Free Flap Reconstruction: a Prospective Time to Deterioration Analysis
- ClinicalTrials.gov ID
- NCT06756763
- Acronym / sponsor ID
- 201402788B0
- Conditions
- Head and Neck Cancer, Free Flap
- Keywords
- Quality of life, Longitudinal, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 3 Jan 2025 (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.
This study examines the quality of life for patients after head and neck free flap reconstruction, both pre-operative and at least 1 year post-operative. It aims to find out what influences quality of life, and whether these changes are stable over time. It will use a new method of analysis called "Time to Deterioration" which tells us when a patient notices a significant change in their quality of life, when subsequently does not get better.
Detailed description
Methods
Prospectively collected quality of life (QoL) study using a longitudinal TTD approach in a large cohort of head and neck free flap reconstruction patients. Questionnaires completed pre-operatively and at outpatient clinic visits, with concomitant examination and complication status recorded. Quality of life data collected by a clinician not involved in the research.
Participants and Setting Participants recruited from Chang Gung Memorial Hospital, Linkou, Taiwan. Inclusion criteria included all patients undergoing free flap reconstruction of benign or malignant head and neck disease, who had completed both pre-operative and a minimum of one post-operative questionnaire, at least 1 year post-operatively. Exclusion criteria included patients that did not undergo free flap reconstruction, extra-oral disease eg scalp, no pre-operative questionnaire, post-operative questionnaire without at least 1 year follow up, and patients unable to consent.
Primary outcome University of Winconsin Quality of Life (UW-QoL) questionnaire (Taiwan mandarin version v4) is a 12-item scale with additional global questions, scored from 0 to 100, with separate Physical and Social component scores providing a composite overall score.
Quality of Life primary outcomes Separate analysis of component scores, rather than overall score, is suggested in UW-QoL scoring guidelines. This study examined Physical component score as the primary outcome.
Missing data Missing data in UW QoL questionairres were handled according to published scoring guidelines, with a minimum 4 components in both physical and social subscores.
Time to Deterioration (TTD) definitions TTD methodology was used to assess changes in QoL over time. TTD is defined as a drop of > 5 points in QoL scores without a subsequent increase > 5 points compared to the previous score. Comparison with previous score accounts for 'response shift' in patient perceptions, whereby patients get accustomed to a new normal by internal recalibration. QoL studies typically use a General Linear Mixed Model approach that does not quantify for this 'response shift'. Using this approach also better accounts for 'reversibility' in QoL . Previous score was used rather than previous best score. An MCID of 5 points has been proposed for TTD methodology which is in line with estimates of 5-10% in the the UW QoL scoring guidelines.
Health Related Quality of Life (HRQoL) Deterioration Free Survival HRQoL deterioration free survival includes death (all cause death) as an event and is akin to overall survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and Neck Reconstruction patients | – | –Head and Neck Reconstruction patients undergoing free flap reconstruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Head and neck disease both benign and maligant
Key inclusion criteria (2 listed)
- free flap reconstruction
- benign or malignant head and neck disease
Key exclusion criteria (3 listed)
- did not undergo free flap reconstruction
- extra-oral disease eg scalp
- patients unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
University of Wisconsin Quality of Life Questionnaire
Time frame: Once at enrollment pre-operatively, and repeated at least 1 year post-operatively
University of Winconsin Quality of Life (UW-QoL) questionnaire (Taiwan mandarin version v4) is a 12-item scale with additional global questions, scored from 0 to 100, with separate Physical and Social component scores providing a composite overall score. Higher scores indicate higher quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Undecided. IPD shared on reasonable request to the authors
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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?
An observational study of Head and Neck Cancer and Free Flap, run by Chang Gung Memorial Hospital 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 2 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: finished, as of the sponsor's last update on 3 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
University of Wisconsin Quality of Life Questionnaire (time frame: Once at enrollment pre-operatively, and repeated at least 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2025.