CancerCOUPLENCT02541162
Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology
A study testing Oral information and interviews in people with Cancer, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oral information and interviews
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jun 2014to 15 Oct 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients and partners declaring itself in couple or having a shared private life;
- Patients diagnosed by an initial cancer, the prognosis for survival of which at the time of the diagnosis is upper to one year;
- Patients and partners of more than 18 years old, mastering the French language, and in measure to give their informed consent
Who cannot join
- Patients having been diagnosed and/or treated for another cancer;
- Patients and partners having a psychiatric disorder (confusional syndrome, psychotic disorders, disrupted reality perception)
- Patients and partners protected by the law, according to articles L.1121-5 to L.1121-8 of the Public health code.
Trial locations and contacts
2 sites in 1 country.
France2 sites
hopital Saint Joseph
Paris, 75014
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments.
Further to this study, the project will be to train and to sensitize the medical staff, or still to develop new activities to meet the needs better of patients and of partners.
Read the detailed description
To answer the objective, investigators set up a longitudinal study of a maximum duration of 18 months to recruit a minimum of 60 couples distributed in two groups:
The inclusion in the study will be made in two phases:
- The couples of the non-interventional group (NI) will be recruited at first to avoid the possibility to of sharing information between patients on their care. Indeed, it is about a comparative study and it is necessary that the couples of the NI group do not know about information proposed to the group I, at the risk of cancelling the effect of the information.
- The couples of the interventional group (I) will so be recruited during the last phase of the study of the NI group, that is approximately 6 months after the beginning of the study.
The choice of the minimal size of participants' sample is stretched out by the necessity of a minimum number of 30 participants by group to make relevant statistical analyses.
Once the information were given to the patients and to the partners, according to the group in which they are included, the participants will perform individually same sets of validated questionnaires at three different point times:
- initial visit: at the inclusion
- intermediate visit: 2 months after the inclusion
- final visit: 6 months after the inclusion
The Questionnaires will be manage through a local statistical analysis. The set of analyses will be led thanks to the statistical software SPSS. Descriptive analyses of the data, the correlations between the variables of the study and finally the tests of comparison will be perform to have an objective assessment criterion for this study.
- Conditions
- Cancer
- Being tested
- Oral information and interviews
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral information and interviewsBehavioural
interviews about sexuality and self experience during the disease
| Study group | Role | What they receive |
|---|---|---|
| INFORMED | Experimental | Interventional Group (I): Couples enrolled during the diagnosis will receive written information as usual about the disease and in addition they benefit special oral interviews and written information about experiences of their sexuality during the illness.The document used for the interventional group is "Sexuality and Cancer" and will be given to couples. (intervention: Oral information and interviews about sexuality and self experience during the disease). Qualitative analysis will be provided by a psychologist Receives: Behavioral: Oral information and interviews |
| ORDINARY USE | No intervention | Non-interventional Group (NI): Couples enrolled during the diagnosis will only receive written information about their experience of disease . The document used fot the non interventional group is "Live during and after cancer"and will be given to couples. Qualitative analysis will be provided by a psychologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion
Measured: Participants will be followed during 6 months
Secondary outcomes (1)
Change from baseline in Sexual Satisfaction Score (ESS) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion
Measured: Participants will be followed during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start11 Jun 2014
- Primary completion15 Oct 2015
- Study completion15 Oct 2017
Why it stopped: The study was suspended because the oncology service decided to adopt the procedure in routine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Beaussier, Pharm D, Study director, CRC - GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541162
- Sponsor's protocol ID
- 2014-A00443-44
- Acronym
- COUPLE
- Status last verified
- Mar 2018
- First submitted
- 21 Aug 2015
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer and Sexual Health : Early Information and Sexual Satisfaction of Couples in Oncology
- ClinicalTrials.gov ID
- NCT02541162
- Acronym / sponsor ID
- COUPLE / 2014-A00443-44
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended because the oncology service decided to adopt the procedure in routine
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 15 Oct 2015 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 4 Sep 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.
In a perspective of improvement of the global care of the patients, investigators wish to estimate, within the oncology department of Paris Saint Joseph Hospital, the impact of a clear, written and oral information, on the sexual satisfaction of the couples during treatments.
Further to this study, the project will be to train and to sensitize the medical staff, or still to develop new activities to meet the needs better of patients and of partners.
Detailed description
To answer the objective, investigators set up a longitudinal study of a maximum duration of 18 months to recruit a minimum of 60 couples distributed in two groups:
The inclusion in the study will be made in two phases:
- The couples of the non-interventional group (NI) will be recruited at first to avoid the possibility to of sharing information between patients on their care. Indeed, it is about a comparative study and it is necessary that the couples of the NI group do not know about information proposed to the group I, at the risk of cancelling the effect of the information.
- The couples of the interventional group (I) will so be recruited during the last phase of the study of the NI group, that is approximately 6 months after the beginning of the study.
The choice of the minimal size of participants' sample is stretched out by the necessity of a minimum number of 30 participants by group to make relevant statistical analyses.
Once the information were given to the patients and to the partners, according to the group in which they are included, the participants will perform individually same sets of validated questionnaires at three different point times:
- initial visit: at the inclusion
- intermediate visit: 2 months after the inclusion
- final visit: 6 months after the inclusion
The Questionnaires will be manage through a local statistical analysis. The set of analyses will be led thanks to the statistical software SPSS. Descriptive analyses of the data, the correlations between the variables of the study and finally the tests of comparison will be perform to have an objective assessment criterion for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INFORMED | Experimental | Behavioral: Oral information and interviewsInterventional Group (I): Couples enrolled during the diagnosis will receive written information as usual about the disease and in addition they benefit special oral interviews and written information about experiences of their sexuality during the illness.The document used for the interventional group is "Sexuality and Cancer" and will be given to couples. (intervention: Oral information and interviews about sexuality and self experience during the disease). Qualitative analysis will be provided by a psychologist |
| ORDINARY USE | No intervention | –Non-interventional Group (NI): Couples enrolled during the diagnosis will only receive written information about their experience of disease . The document used fot the non interventional group is "Live during and after cancer"and will be given to couples. Qualitative analysis will be provided by a psychologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients and partners declaring itself in couple or having a shared private life;
- Patients diagnosed by an initial cancer, the prognosis for survival of which at the time of the diagnosis is upper to one year;
- Patients and partners of more than 18 years old, mastering the French language, and in measure to give their informed consent
Key exclusion criteria (3 listed)
- Patients having been diagnosed and/or treated for another cancer;
- Patients and partners having a psychiatric disorder (confusional syndrome, psychotic disorders, disrupted reality perception)
- Patients and partners protected by the law, according to articles L.1121-5 to L.1121-8 of the Public health code.
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 |
|---|---|---|
| Oral information and interviewsinterviews about sexuality and self experience during the disease | Behavioural | INFORMED |
Primary outcome
Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
Time frame: Participants will be followed during 6 months
3 times points: Randomization (Day 1), 2 months and 6 months post-inclusion
1 secondary outcome
Change from baseline in Sexual Satisfaction Score (ESS) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed
Time frame: Participants will be followed during 6 months
Results and safety
The study was stopped early (reason given: The study was suspended because the oncology service decided to adopt the procedure in routine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
Helene Beaussier, Pharm D study director
CRC - GHPSJ
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral information and interviews in people with Cancer, run by Fondation Hôpital Saint-Joseph 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Mar 2018. 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. 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 stopped early (reason given: The study was suspended because the oncology service decided to adopt the procedure in routine). Results are not available in the source record.
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?
Change from baseline in Quality Life (QLQ C30) due to a specific information about the sexuality on the sexual satisfaction of the couples, assessed (time frame: Participants will be followed during 6 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 14 Mar 2018.