OncologyNCT03290352
Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer
An observational study of Oncology, run by Taipei Medical University.
Trial summary
This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2010to 30 Jun 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Head and neck cancer patients undergoing free-flap reconstruction
Who may be able to join
- Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
- Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital
Who cannot join
- Patients with distant metastasis identified in their medical records, or
- Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps
About this study
Official title: Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer Who Underwent Free Flap Reconstruction
This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.
Read the detailed description
The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology. In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy. A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators. In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making. Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.
- Conditions
- Oncology
- Being tested
- Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer patients | Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study. However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of head and neck cancer patients with free-flap reconstruction
Measured: 3 years 8 months
Secondary outcomes (1)
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
Measured: 3 years 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start1 Nov 2010
- Primary completion30 Jun 2014
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Chin Lin, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290352
- Sponsor's protocol ID
- HKU_1
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer Who Underwent Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT03290352
- Acronym / sponsor ID
- HKU_1
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2010 (actual)
- Primary completion
- 30 Jun 2014 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 21 Sep 2017 (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 shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction. In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.
Detailed description
The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology. In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy. A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators. In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making. Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer patients | – | Other: QuestionnairePatients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study. However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Head and neck cancer patients undergoing free-flap reconstruction
Key inclusion criteria (2 listed)
- Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
- Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital
Key exclusion criteria (2 listed)
- Patients with distant metastasis identified in their medical records, or
- Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps
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 |
|---|---|---|
| QuestionnairePatients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction. | Other | Head and neck cancer patients |
Primary outcome
Overall survival of head and neck cancer patients with free-flap reconstruction
Time frame: 3 years 8 months
1 secondary outcome
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
Time frame: 3 years 8 months
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 21 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Taipei Medical University.
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 2 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall survival of head and neck cancer patients with free-flap reconstruction (time frame: 3 years 8 months). 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 21 Sep 2017.