NCT03336177

Brief Summary

Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer. The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

October 19, 2017

Last Update Submit

August 7, 2018

Conditions

Keywords

gynecologycancerageddelayhelp-seeking behaviorqualitative researchsemiopragmatic analysispsychodynamic analysis

Outcome Measures

Primary Outcomes (1)

  • Experience of help-seeking period for low gynecological cancers.

    Qualitative interview performed at one occasion where the patient describes the experience of the help seeking period she has passed through.

    1 day

Secondary Outcomes (1)

  • Motivators and barriers to help-seeking for low gynecological cancers.

    1 day

Interventions

Patients will be interviewed by open-ended questions face to face concerning their past experiences. The recorded interview will be transcribed and analyzed by psychodynamic and semio-pragmatic approach.

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women of 65 years or more treated or followed at Lorraine Institute of Oncology Diagnosed after 65 years or later of a low gynecological cancer

You may qualify if:

  • Women of 65 years or more treated or followed at Lorraine Institute of Oncology
  • Diagnosed after 65 years or later of a low gynecological cancer
  • Without diagnosis of dementia
  • Retained ability to express by herself without assistance
  • Affiliated to public health system
  • Informed and having expressed her non-opposition

You may not qualify if:

  • Women under 65 or diagnosed before being 65 of a low gynecological cancer
  • Diagnosed of dementia
  • No longer to express herself
  • Patient deprived of freedom

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine (ICL)

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Signs and SymptomsNeoplasmsHelp-Seeking Behavior

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Officials

  • MARCHAL FREDERIC, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2017

First Posted

November 8, 2017

Study Start

October 30, 2017

Primary Completion

March 12, 2018

Study Completion

July 27, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations