Gynecologic CancerCODEGY65NCT03336177
Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.
An observational study of Gynecologic Cancer and Symptoms and Signs, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Symptoms and Signs, Aged
- What is being tested?
- Semi-structured face to face interviews.
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2017to 27 Jul 2018
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach
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.
Read the detailed description
Our study assess the reasons for which the patient took time to go to the doctor despite of their symptoms. We use a qualitative methodology. Our study categorizes lived experiences, recorded in semistructured interview transcripts. We use psychodynamic and semiopragmatic analyses of the discourse to obtain hypotheses about possible reasons of the delay in the help-seeking process."
- Conditions
- Gynecologic Cancer, Symptoms and Signs, Aged
- Being tested
- Semi-structured face to face interviews.
- Keywords
- gynecology, cancer, aged, delay, help-seeking behavior, qualitative research, semiopragmatic analysis, psychodynamic analysis
- Medical subject headings
- Signs and Symptoms, Neoplasms, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured face to face interviews.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Motivators and barriers to help-seeking for low gynecological cancers.
qualitative methodology using verbal data analysis of semi-structured interview.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start30 Oct 2017
- Primary completion12 Mar 2018
- Study completion27 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARCHAL FREDERIC, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336177
- Sponsor's protocol ID
- 2017-A01574-49
- Acronym
- CODEGY65
- Status last verified
- Aug 2018
- First submitted
- 19 Oct 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach
- ClinicalTrials.gov ID
- NCT03336177
- Acronym / sponsor ID
- CODEGY65 / 2017-A01574-49
- Conditions
- Gynecologic Cancer, Symptoms and Signs, Aged
- Keywords
- gynecology, cancer, aged, delay, help-seeking behavior, qualitative research, semiopragmatic analysis, psychodynamic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 27 Jul 2018 (actual)
- First posted
- 8 Nov 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.
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.
Detailed description
Our study assess the reasons for which the patient took time to go to the doctor despite of their symptoms. We use a qualitative methodology. Our study categorizes lived experiences, recorded in semistructured interview transcripts. We use psychodynamic and semiopragmatic analyses of the discourse to obtain hypotheses about possible reasons of the delay in the help-seeking process."
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Semi-structured face to face interviews.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. | Other | – |
Primary outcome
Experience of help-seeking period for low gynecological cancers.
Time frame: 1 day
Qualitative interview performed at one occasion where the patient describes the experience of the help seeking period she has passed through.
1 secondary outcome
Motivators and barriers to help-seeking for low gynecological cancers.
Time frame: 1 day
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 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
MARCHAL FREDERIC, MD principal investigator
Institut de Cancérologie de Lorraine
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 Gynecologic Cancer and Symptoms and Signs, run by Institut de Cancérologie de Lorraine at 1 site 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: finished, as of the sponsor's last update on 8 Aug 2018. 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 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?
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?
Experience of help-seeking period for low gynecological cancers. (time frame: 1 day). 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 8 Aug 2018.