Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
315 participants
OBSERVATIONAL
2015-03-01
2024-12-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postoperative Complication After Free Flap Reconstruction for Head and Neck Cancer
NCT04326088
Comparison of Quality of Life in Patients with Differentiated Thyroid Carcinoma Undergoing Different Surgery
NCT06037174
Oral Cancer With Wide Excision and Free Flap Reconstruction
NCT03776578
Hürthle Cell Carcinoma and Follicular Thyroid Carcinoma
NCT05968196
Quality of Life After Laser Cordectomy in Early Glottic Cancer
NCT02184403
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Head and Neck Reconstruction patients
Head and Neck Reconstruction patients undergoing free flap reconstruction
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* benign or malignant head and neck disease
Exclusion Criteria
* extra-oral disease eg scalp
* patients unable to consent
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital
Linkou District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201402788B0
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.