Cancer of the Upper Aero-digestive Tract and Socio-profes... | NCT01788878

Studies
Cancer of the Upper Aero-digestive Tract and Socio-professional Future

NCT01788878

Sponsor

Centre Oscar Lambret

Status

Unknown status

Last Update Posted

Jul 26, 2016Estimated

Enrollment

46Actual

Phase

Not Applicable

Conditions

Upper Aerodigestive Tract Neoplasms

Interventions

Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Aug 2016Estimated

Completion Date

May 2018Estimated

First Submitted Date

Jan 31, 2013

First Submission Date that Met QC Criteria

Feb 8, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Name	Class
University Charles-de-Gaulle	OTHER
Région Nord-Pas de Calais, France	OTHER
University Hospital, Lille	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Questionnaires	Experimental	completion of questionnaires	Behavioral: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main psycho-medical and socio-professional determinants associated with return to work at 18 months after diagnosis		At month 18

Secondary Outcomes

Measure	Description	Time Frame
Period until return to work (also part-time work)		At month 6, month 12, month 18
Modalities, period and stability of this return to work		At month 6, month 12, month 18

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophie FANTONI, Pr	CHRU de Lille	Study Director
Jean-Louis LEFEBVRE, Pr	Centre Oscar Lambret	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Caen		Caen		14 033	France
Centre François Baclesse

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided