Prostate CancerPRODUCANNCT03572621
Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
A study testing Therapeutic education, Collection of data concerning their sexuality and Participation in people with Prostate Cancer, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Therapeutic education, Collection of data concerning their sexuality and Participation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Feb 2020to Sep 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:
- Aged over 18
- presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips.
- affiliated to a social security scheme.
- and having been informed and given informed consent to participation in the program.
Who cannot join
- Refusal of participation, signature of consent,
- protected major patients, under guardianship or curators.
- Patients unable to understand the course of the study
- Patient with a documented history of cognitive or psychiatric disorders.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Hédouard Herriot
Lyon, 69003
CUZIN Béatrice, MD
Béatrice CUZIN, MD
- Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite
Damien CARNICELLI, MD, damien.carnicelli@chu-lyon.fr
Damien CARNICELLI, MD
About this study
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.
There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.
- Conditions
- Prostate Cancer
- Being tested
- Therapeutic education, Collection of data concerning their sexuality, Participation
- Keywords
- Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educationOther
Patients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half.
Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation.
Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation.
Session 3: Presentation of available treatments, start intracavernous injections.
Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised.
Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid.
Collection of data concerning their sexualityOther
Patients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions).
ParticipationOther
Participation in a therapeutic education day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group are offered to participate in a 6-session therapeutic education program on sexuality, ranging from 15 days before surgery to approximately 3 months after. This in addition to the current care by the teams of care about sexual rehabilitation (information and medication prescriptions). Receives: Other: Therapeutic education |
| Control group | Sham comparator | Patient without therapeutic education. Receives: Other: Collection of data concerning their sexuality |
| Partner | Other | Patient's partner. Receives: Other: Participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the quality of sexual life of patients treated with radical prostatectomy (PR)
Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18.
Measured: 18 months
Secondary outcomes (14)
Sexual function
Measure of The International Index of Erectile Function (IIEF-EF) score. This validated score measures the erectile component.
Measured: Month 1, 6, 12 and 18
General quality of life
Signing of questionnaire EuroQol-D5 (EQ-D5)
Measured: Month 1, 6, 12 and 18
Sexual quality of life of the partner
Index of Sexual Life (ISL) questionnaire, validated questionnaire specifically created to assess the impact of erectile dysfunction (ED) in the partner.
Measured: Month 1, 6, 12 and 18
Number of erections obtained in the last month
Patient questionnaire to be filled every month at home by the patient and the partner
Measured: Month 1, 6, 12 and 18
Number of reports deemed satisfactory
Patient questionnaire to be filled every month at home by the patient and the partner
Measured: Month 1, 6, 12 and 18
Number of intracavernous injections performed per week
Patient questionnaire to be filled every month at home by the patient and the partner
Measured: Month18
Patient Activation Measure (questionnaire PAM)
Measured: Month18
Erection Hardness Score (EHS)
Measured: Month 1, 6, 12 and 18
Continence: urinary handicap measurement scale (MHU)
Measured: Month 1, 6, 12 and 18
Penis size (cm)
Measured: Month 1, 6, 12 and 18
Knowledge acquisition measured by quizz build for the study made of simulated cases
Measured: Month 1, 6, 12 and 18
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
Measured: Month 1, 6, 12 and 18
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
Measured: Month 6 and18
Depression level measured by the Hospital Anxiety and Depression (HAD) scale
Measured: Month 6 and18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start3 Feb 2020
- Primary completionFeb 2023 (estimated)
- Study completionSep 2024 (estimated)
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Etienne TERRIER, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572621
- Sponsor's protocol ID
- 69HCL17_0010
- Acronym
- PRODUCAN
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2018
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality
- ClinicalTrials.gov ID
- NCT03572621
- Acronym / sponsor ID
- PRODUCAN / 69HCL17_0010
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Jun 2018 (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.
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.
There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Therapeutic educationPatients in the experimental group are offered to participate in a 6-session therapeutic education program on sexuality, ranging from 15 days before surgery to approximately 3 months after. This in addition to the current care by the teams of care about sexual rehabilitation (information and medication prescriptions). |
| Control group | Sham comparator | Other: Collection of data concerning their sexualityPatient without therapeutic education. |
| Partner | Other | Other: ParticipationPatient's partner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients treated in urology consultation at the University Hospital of Lyon Sud or Edouard Herriot:
- Aged over 18
- presenting a cancerous pathology of the prostate having an indication of radical prostatectomy with or without preservation of the neurovascular strips.
- affiliated to a social security scheme.
- and having been informed and given informed consent to participation in the program.
Key exclusion criteria (4 listed)
- Refusal of participation, signature of consent,
- protected major patients, under guardianship or curators.
- Patients unable to understand the course of the study
- Patient with a documented history of cognitive or psychiatric disorders.
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 |
|---|---|---|
| Therapeutic educationPatients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half. Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation. Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation. Session 3: Presentation of available treatments, start intracavernous injections. Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised. Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid. | Other | Experimental group |
| Collection of data concerning their sexualityPatients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions). | Other | Control group |
| ParticipationParticipation in a therapeutic education day. | Other | Partner |
Primary outcome
Change the quality of sexual life of patients treated with radical prostatectomy (PR)
Time frame: 18 months
Comparison of the difference in self-Esteem quotation and Relationship (SEAR) questionnaire, between the experimental group and control, between inclusion and Month 18.
14 secondary outcomes
Sexual function
Time frame: Month 1, 6, 12 and 18
General quality of life
Time frame: Month 1, 6, 12 and 18
Sexual quality of life of the partner
Time frame: Month 1, 6, 12 and 18
Number of erections obtained in the last month
Time frame: Month 1, 6, 12 and 18
Number of reports deemed satisfactory
Time frame: Month 1, 6, 12 and 18
Number of intracavernous injections performed per week
Time frame: Month18
Patient Activation Measure (questionnaire PAM)
Time frame: Month18
Erection Hardness Score (EHS)
Time frame: Month 1, 6, 12 and 18
Continence: urinary handicap measurement scale (MHU)
Time frame: Month 1, 6, 12 and 18
Penis size (cm)
Time frame: Month 1, 6, 12 and 18
Knowledge acquisition measured by quizz build for the study made of simulated cases
Time frame: Month 1, 6, 12 and 18
acquisition of sexual intercourse management skills measured by quizz build for the study made of simulated cases
Time frame: Month 1, 6, 12 and 18
Anxiety level measured by the Hospital Anxiety and Depression (HAD) scale
Time frame: Month 6 and18
Depression level measured by the Hospital Anxiety and Depression (HAD) scale
Time frame: Month 6 and18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
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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
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic education, Collection of data concerning their sexuality and Participation in people with Prostate Cancer, run by Hospices Civils de Lyon at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien CARNICELLI, MD (04 72 67 88 01 ext. +33, damien.carnicelli@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the quality of sexual life of patients treated with radical prostatectomy (PR) (time frame: 18 months). 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 7 Mar 2022.