Upper Aerodigestive Tract NeoplasmsCARDELNCT01788878
Cancer of the Upper Aero-digestive Tract and Socio-professional Future
A study testing Questionnaires in people with Upper Aerodigestive Tract Neoplasms, run by Centre Oscar Lambret at 8 sites in France.
Trial summary
The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Upper Aerodigestive Tract Neoplasms
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesFrance
- Study dates
- Feb 2014to May 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age at diagnosis ≥ 18 to ≤ 55 years
- Employed at the entry into the care pathway
- Presenting an upper aero-digestive tract cancer (excluding nasal cavities), stage I, II and III, under a first anti-tumor treatment (surgery, radiotherapy, or chemotherapy)
- Patient mastering the French language
- Affiliated to the social security system
- Consent signed by the patient before the implementation of any specific study procedure
Who cannot join
- Having been treated for another cancer before (except skin cancer and / or prostate)
- Metastatic disease from the outset
- Patient unable to submit to a regular follow-up
- Presenting psychiatric disorders
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Caen
Caen, 14 033
Centre François Baclesse
Caen, 14076
Hôpital privé de l'Estuaire
Le Havre, 76620
Centre Oscar Lambret
Lille, 59020
CHRU de Lille
Lille, 59037
Hôpital de la Timone
Marseille, 13385
Centre Antoine Lacassagne
Nice, 06054
CHU de Rouen
Rouen, 760310
About this study
The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.
Read the detailed description
Socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer.
A series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. Medical data will be collected via the CRF.
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Being tested
- Questionnaires
- Keywords
- socio-professional future
- 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.
QuestionnairesBehavioural
A first series of questionnaires will be given by the investigator at patients before treatment (inclusion visit) and then the questionnaires will be given at the follow-up visits planned at 6 months, 12 months and 18 months.
Medical data will be collected via the CRF.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires | Experimental | completion of questionnaires Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
Measured: At month 18
Secondary outcomes (5)
Period until return to work (also part-time work)
Measured: At month 6, month 12, month 18
Modalities, period and stability of this return to work
Measured: At month 6, month 12, month 18
Alternatives to return to work (retirement, disability, etc ...)
Measured: At month 6, month 12, month 18
Psychological factors that might interfere with the behaviors to return to work
Measured: At baseline, Month 6, Month 12, Month 18
Information collected in the perceived support part of the questionnaire
Measured: At baseline, Month 6, Month 12, Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2016 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Aerodigestive Tract NeoplasmsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- University Charles-de-Gaulle, Région Nord-Pas de Calais, France, University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Sophie FANTONI, Pr, Study director, CHRU de LilleJean-Louis LEFEBVRE, Pr, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788878
- Sponsor's protocol ID
- CARDEL-1211
- Acronym
- CARDEL
- Status last verified
- Jul 2016
- First submitted
- 31 Jan 2013
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer of the Upper Aero-digestive Tract and Socio-professional Future
- ClinicalTrials.gov ID
- NCT01788878
- Acronym / sponsor ID
- CARDEL / CARDEL-1211
- Conditions
- Upper Aerodigestive Tract Neoplasms
- Keywords
- socio-professional future
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- University Charles-de-Gaulle, Région Nord-Pas de Calais, France, University Hospital, Lille
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 11 Feb 2013 (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 aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.
Detailed description
Socio-professional, medical, psychological, demographic, economic, and educational data collection in patients within the care pathway of upper aero-digestive tract cancer.
A series of questionnaires will be presented at the initial consultation and then at 6 months, at 12 months and at 18 months during follow-up visits. Medical data will be collected via the CRF.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | Experimental | Behavioral: Questionnairescompletion of questionnaires |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age at diagnosis ≥ 18 to ≤ 55 years
- Employed at the entry into the care pathway
- Presenting an upper aero-digestive tract cancer (excluding nasal cavities), stage I, II and III, under a first anti-tumor treatment (surgery, radiotherapy, or chemotherapy)
- Patient mastering the French language
- Affiliated to the social security system
Key exclusion criteria (4 listed)
- Having been treated for another cancer before (except skin cancer and / or prostate)
- Metastatic disease from the outset
- Patient unable to submit to a regular follow-up
- Presenting psychiatric disorders
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 |
|---|---|---|
| QuestionnairesA first series of questionnaires will be given by the investigator at patients before treatment (inclusion visit) and then the questionnaires will be given at the follow-up visits planned at 6 months, 12 months and 18 months. Medical data will be collected via the CRF. | Behavioural | Questionnaires |
Primary outcome
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis
Time frame: At month 18
5 secondary outcomes
Period until return to work (also part-time work)
Time frame: At month 6, month 12, month 18
Modalities, period and stability of this return to work
Time frame: At month 6, month 12, month 18
Alternatives to return to work (retirement, disability, etc ...)
Time frame: At month 6, month 12, month 18
Psychological factors that might interfere with the behaviors to return to work
Time frame: At baseline, Month 6, Month 12, Month 18
Information collected in the perceived support part of the questionnaire
Time frame: At baseline, Month 6, Month 12, Month 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Upper Aerodigestive Tract Neoplasms
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
Active, not recruitingPhase 2
Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC
Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies
Head and Neck Cancer, Lung Cancer
Active, not recruitingPhase 2
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands
Active, not recruitingObservational study
Integrated Molecular Profiling in Advanced Cancers Trial
Breast Cancer, Non-small Cell Lung Cancer
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.
Sophie FANTONI, Pr study director
CHRU de Lille
Jean-Louis LEFEBVRE, Pr study director
Centre Oscar Lambret
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Upper Aerodigestive Tract Neoplasms, run by Centre Oscar Lambret at 8 sites in France.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis (time frame: At month 18). 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 26 Jul 2016.