Prostate CancerPEPs PROSTATENCT02379260
Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer
A study testing Interview with a sociologist in people with Prostate Cancer, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial summary
The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality. This study is carried out in two steps : Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Interview with a sociologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Nov 2015
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients followed in urology department Lyon Sud CH:
- Aged over 18 year
- Having a prostate cancer
- Treated with radical prostatectomy with or without conservation strips neuro vascular
- More than 1 month postoperative
- Having a normal preoperative erectile function defined by a score IIEF EF ≥ 26.
- And who signed the informed consent form for participation in the study
Who cannot join
- Score preoperative IIEF EF <26
- Refusal of participation, signed consent major patients protected under guardianship.
- Patients unable to understand the course of the study
- Patient (s) with a documented history of cognitive or psychiatric disorders.
- Geographical remoteness of more than 100 Kms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.
This study is carried out in two steps :
- Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
- Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.
Read the detailed description
8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.
Focus groups will be conduct to :
- Identify the representations associated with erectile dysfunction
- Identify the representations related to treatments for erectile dysfunction.
- Score patient knowledge about treatments and their managements.
- Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
- Assessing the needs and expectations of patients
- Conditions
- Prostate Cancer
- Being tested
- Interview with a sociologist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview with a sociologistOther
| Study group | Role | What they receive |
|---|---|---|
| Interview | Other | Patients and urologists will be interview by a sociologist. Receives: Other: Interview with a sociologist |
| Focus Groups | Other | Focus groups contain 5-7 patients. Groups will be stratified according to socio-economic levels and according to treatment (radical prostatectomy with conservation or without preservation of the neuro vascular strips). Receives: Other: Interview with a sociologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic and comparative analysis of the recorded interviews
Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne TERRIER, MD, Principal investigator, CH Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379260
- Sponsor's protocol ID
- 2014-11
- Acronym
- PEPs PROSTATE
- Status last verified
- Feb 2016
- First submitted
- 27 Feb 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02379260
- Acronym / sponsor ID
- PEPs PROSTATE / 2014-11
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Mar 2015 (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 is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.
This study is carried out in two steps :
- Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included
- Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.
Detailed description
8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.
Focus groups will be conduct to :
- Identify the representations associated with erectile dysfunction
- Identify the representations related to treatments for erectile dysfunction.
- Score patient knowledge about treatments and their managements.
- Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.
- Assessing the needs and expectations of patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interview | Other | Other: Interview with a sociologistPatients and urologists will be interview by a sociologist. |
| Focus Groups | Other | Other: Interview with a sociologistFocus groups contain 5-7 patients. Groups will be stratified according to socio-economic levels and according to treatment (radical prostatectomy with conservation or without preservation of the neuro vascular strips). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients followed in urology department Lyon Sud CH:
- Aged over 18 year
- Having a prostate cancer
- Treated with radical prostatectomy with or without conservation strips neuro vascular
- More than 1 month postoperative
Key exclusion criteria (5 listed)
- Score preoperative IIEF EF <26
- Refusal of participation, signed consent major patients protected under guardianship.
- Patients unable to understand the course of the study
- Patient (s) with a documented history of cognitive or psychiatric disorders.
- Geographical remoteness of more than 100 Kms.
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 |
|---|---|---|
| Interview with a sociologist | Other | Focus Groups, Interview |
Primary outcome
Thematic and comparative analysis of the recorded interviews
Time frame: 2 hours
Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.
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 26 Feb 2016.
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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.
Jean-Etienne TERRIER, MD principal investigator
CH Lyon Sud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview with a sociologist in people with Prostate Cancer, run by Institut de Cancérologie de la Loire 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 7 inclusion and 5 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 26 Feb 2016. 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?
Thematic and comparative analysis of the recorded interviews (time frame: 2 hours). 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 Feb 2016.