Advanced Stage Head and Neck CancerNCT00578032
Reconstructive Surgery For Head And Neck Cancer Patients
An observational study of Advanced Stage Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to better understand the changes in symptoms and overall quality of life after head and neck surgery and reconstruction. "Quality of Life" means how you feel about your life as a result of your disease and its treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Stage Head and Neck Cancer
- What is being tested?
- Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Oct 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and and neck malignancies hat require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.
Who may be able to join
- Patients undergoing surgical resection and reconstruction for every stage head and neck malignancies at Memorial Sloan-Kettering Cancer Center.
- Patients at least 21 years of age
Who cannot join
- Patients who are less than 21 years old
- Patients who do not speak the English language
- Patients who are unable to comprehend the content of the questionnaires due to psychiatric disorders or cognitive impairment
- Patients who cannot complete the pre-operative questionnaires during consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Reconstructive Surgery For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief
The goal of this study is to better understand the changes in symptoms and overall quality of life after head and neck surgery and reconstruction. "Quality of Life" means how you feel about your life as a result of your disease and its treatment. Learning about changes in patients' quality of life will help doctors and future patients make more informed treatment decisions.
Read the detailed description
This prospective, longitudinal study will evaluate patient-reported quality of life and symptomatology immediately prior to and for up to one year following surgical resection and reconstruction head and neck malignancies.Patients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.Quality of life and symptom relief will be evaluated by both domain and disease specific questionnaires at four time points: pre-operatively, and 3 months (±1 month), 6 months (±1), and 9 months (-1 and +3) post-operatively. These assessment points represent clinically significant events in patients' post-operative course following head and neck surgery. Studies have shown that quality of life decreases significantly at three months after surgery but then reapproaches baseline levels around one year (1). Pre-operative responses will serve as the baseline for comparison.
- Conditions
- Advanced Stage Head and Neck Cancer
- Being tested
- Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment
- Keywords
- head, neck, cancer, reconstruction, quality of life, 07-150
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative AssessmentBehavioural
All patients will complete the predefined questionnaires at the following four time points along the course of their care: preoperative clinic visit, and 3 months (±1 month), 6 months (±1), and 9 months (1 and +3) post-operatively. Completion of the questionnaires should take approximately 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate. Receives: Behavioral: Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe overall pt-reported health-related QOL and cancer related symptoms pre-operatively and at 3, 6 and 9 mos following surgical resection and reconstruction for head & neck malignancies
Measured: 1 year
Secondary outcomes (1)
To describe changes in patient-reported health-related quality of life and cancer-related symptoms within 9 or 12 months following surgical resection and reconstruction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Stage Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Pusaic, MD, MHS, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578032
- Sponsor's protocol ID
- 07-150
- Status last verified
- Oct 2017
- First submitted
- 18 Dec 2007
- Last updated
- 19 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Surgery For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief
- ClinicalTrials.gov ID
- NCT00578032
- Acronym / sponsor ID
- 07-150
- Conditions
- Advanced Stage Head and Neck Cancer
- Keywords
- head, neck, cancer, reconstruction, quality of life, 07-150
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Dec 2007 (estimated)
- 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 goal of this study is to better understand the changes in symptoms and overall quality of life after head and neck surgery and reconstruction. "Quality of Life" means how you feel about your life as a result of your disease and its treatment. Learning about changes in patients' quality of life will help doctors and future patients make more informed treatment decisions.
Detailed description
This prospective, longitudinal study will evaluate patient-reported quality of life and symptomatology immediately prior to and for up to one year following surgical resection and reconstruction head and neck malignancies.Patients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.Quality of life and symptom relief will be evaluated by both domain and disease specific questionnaires at four time points: pre-operatively, and 3 months (±1 month), 6 months (±1), and 9 months (-1 and +3) post-operatively. These assessment points represent clinically significant events in patients' post-operative course following head and neck surgery. Studies have shown that quality of life decreases significantly at three months after surgery but then reapproaches baseline levels around one year (1). Pre-operative responses will serve as the baseline for comparison.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative AssessmentPatients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and and neck malignancies hat require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.
Key inclusion criteria (2 listed)
- Patients undergoing surgical resection and reconstruction for every stage head and neck malignancies at Memorial Sloan-Kettering Cancer Center.
- Patients at least 21 years of age
Key exclusion criteria (4 listed)
- Patients who are less than 21 years old
- Patients who do not speak the English language
- Patients who are unable to comprehend the content of the questionnaires due to psychiatric disorders or cognitive impairment
- Patients who cannot complete the pre-operative questionnaires during consent
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 |
|---|---|---|
| Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative AssessmentAll patients will complete the predefined questionnaires at the following four time points along the course of their care: preoperative clinic visit, and 3 months (±1 month), 6 months (±1), and 9 months (1 and +3) post-operatively. Completion of the questionnaires should take approximately 30 minutes | Behavioural | 1 |
Primary outcome
To describe overall pt-reported health-related QOL and cancer related symptoms pre-operatively and at 3, 6 and 9 mos following surgical resection and reconstruction for head & neck malignancies
Time frame: 1 year
1 secondary outcome
To describe changes in patient-reported health-related quality of life and cancer-related symptoms within 9 or 12 months following surgical resection and reconstruction.
Time frame: 2 years
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 19 Oct 2017.
- Memorial Sloan-Kettering web siteLink provided by the sponsor.
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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.
Andrea Pusaic, MD, MHS principal investigator
Memorial Sloan Kettering Cancer Center
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 Advanced Stage Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 4 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 19 Oct 2017. 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 United States. 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?
To describe overall pt-reported health-related QOL and cancer related symptoms pre-operatively and at 3, 6 and 9 mos following surgical resection and reconstruction for head & neck malignancies (time frame: 1 year). 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 19 Oct 2017.