OncologyNCT03166774
Support of the Sexual Health in Oncology
An observational study of Oncology and Sexual Health, run by Fondation Hôpital Saint-Joseph.
Trial summary
Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health. There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Sexual Health
- What is being tested?
- Program of support of the sexual health
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2016to 6 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient followed in oncology
Who may be able to join
- all patient consulting in oncology service
- age > 18 years
- accepting to participate
Who cannot join
- Age< 18 years
- Refusing to participate
About this study
Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health.
There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner .
Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs
- Conditions
- Oncology, Sexual Health
- Being tested
- Program of support of the sexual health
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program of support of the sexual healthOther
Patients included in the study have to answer to a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patient consulting in oncology ervice | Program of support of the sexual health in oncology by questionnaire Receives: Other: Program of support of the sexual health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of the care measurement program
assessment of data recorded on questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start6 Jun 2016
- Primary completion6 Jun 2017
- Study completion6 Jun 2017 (estimated)
Why it stopped: The study stopped because the the project was abandoned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra SCHULTZ, Psychologist, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166774
- Sponsor's protocol ID
- AssO
- Status last verified
- Aug 2018
- First submitted
- 24 May 2017
- Last updated
- 9 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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Support of the Sexual Health in Oncology
- ClinicalTrials.gov ID
- NCT03166774
- Acronym / sponsor ID
- AssO
- Conditions
- Oncology, Sexual Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study stopped because the the project was abandoned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 6 Jun 2016 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (estimated)
- First posted
- 25 May 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.
Implementation of sexual health support program in oncology department. This program is organized in 3 axes. One is to inform the side effects of treatment on sexual health.
There is a counselling team (nurse, esthetician,sexologue..etc) to raise the subject with patient and partner .
Finally, the oncologist continue during the treatment to evaluate the benefit of this program and adapt their counselling according to the needs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient consulting in oncology ervice | – | Other: Program of support of the sexual healthProgram of support of the sexual health in oncology by questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient followed in oncology
Key inclusion criteria (3 listed)
- all patient consulting in oncology service
- age > 18 years
- accepting to participate
Key exclusion criteria (2 listed)
- Age< 18 years
- Refusing to participate
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 |
|---|---|---|
| Program of support of the sexual healthPatients included in the study have to answer to a questionnaire | Other | patient consulting in oncology ervice |
Primary outcome
Benefit of the care measurement program
Time frame: Day 1
assessment of data recorded on questionnaire
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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.
Alexandra SCHULTZ, Psychologist principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Sexual Health, run by Fondation Hôpital Saint-Joseph.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Benefit of the care measurement program (time frame: Day 1). 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 9 Aug 2018.