Hereditary Breast and Ovarian Cancer SyndromeNCT02705924
Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk
A study testing psychoeducation in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Centre Jean Perrin at 1 site in France.
Trial summary
Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hereditary Breast and Ovarian Cancer Syndrome
- What is being tested?
- psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to 14 Sep 2021
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must belong to HBOC families,
- aged between 18 and 40 years
- Single or couple with a desire to have a child
- without any personal history of cancer.
- must have consulted at the oncogenetics department of the CCC Jean Perrin
- tested for a BRCA mutation.
Show all 9Show fewer
- mutation carrier in case of a known familial BRCA mutation, else exposed to a high familial HBOC risk (Eisinger score ≥ 6 or Manchester score ≥ 16)
- must live in Auvergne region (middle France)
- signed an informed consent before inclusion.
Who cannot join
- pregnant women
- person who cannot answer questionnaires: language difficulties and/or cannot write in French correctly.
- no possible connection to our web-site
- psychiatric troubles and/or ongoing treatments preventing from a week-end stay in a SPA resort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk
Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Unfortunately, these women face these issues at a key moment of there identity construction (self, relationship, sexuality) while they are not yet concerned by health prevention measures. A special psychoeducational intervention was designed to help these women to better cope with these difficulties.
Intervention consists in a week-end session in a thermal center (SPA) during which they will attend short conferences given by specialists (prevention measures, prophylactic surgery, assisted procreation, epidemiology...) and participate to role games and group sharing.
Intervention will be evaluated using self-questionnaires completed before intervention and during the following year.
Read the detailed description
Background: Young women exposed to a high hereditary breast/ovaries cancer (HBOC) risk are particularly vulnerable: they are ignored by health prevention measures; they are embedded in a stream of contradictory information ( medicine, media, internet); they may feel concerned by surgical prevention issues at a key moment of there identity construction (self, relationship, sexuality). A special psychoeducational intervention was designed to help these women to better cope with these difficulties.
Methods/design: the study consists in a prospective randomized trial including childless young female counselees (18-40 years) of CCC Jean Perrin oncogenetics department, belonging to HBOC families either BRCA-mutated or not. They will be invited to attend a weekend group session in a SPA resort and participate to a series of short expert conferences and to focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (waiting list) will enable us to evaluate the intervention effect, by comparing the evolution of questionnaires scores between inclusion and 6-month post-intervention. Main end-point is an increase of the Hert Hope Inventory of at least one standard deviation. Secondary endpoints investigate self-esteem, anxiety-trait, anxiety-state, ways of coping and quality of life. Participants will be randomized 1:1 to the first or the second session so that groups are comparable. Session will be cost-free for participants.
- Being tested
- psychoeducation
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationBehavioural
Participants will attend conferences where experts present the state of the art in various domains:
- Latest knowledge in oncogenetics
- Recommendations and morbidity of prophylactic breast surgeries and annexectomy
- Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits
- How to perform the periodic breast screening
- Assisted medical procreation and embryo selection
- Importance of nutrition and physical activity as risk modulator
- Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)?
- Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening.
The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducational intervention | Experimental | group participating to the first psychoeducational intervention: it consists in a week-end session in a SPA center including several conferences about HBOC familial risk, cancer prevention, prophylactic possibilities (surgery), recommendations about nutrition and physical activity a risk modulators, assisted medical procreation and embryo selection, social support...). Besides conferences, Moreno role games and group sharing are organized under the supervision of a psychotherapist. Receives: Behavioral: psychoeducation |
| Waiting list | Other | delayed intervention: group participating to the second psychoeducational intervention (6 months later). Intervention is same as in the intervention arm but it is delayed. Because questionnaires are completed before this second intervention in both arms and allocation to arms are randomized, it represents an adequate control group. Receives: Behavioral: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in expectations measured using the Hert Hope Inventory questionnaire
Hert Hope Inventory global score [Herth, 1992, 2000] is used to evaluate expectations of participants. It contains only 12 simple proposals quoted using a 4-point Likert scale ranking from 1 = "strongly disagree" to 4 = "strongly agree". Its internal structure is composed of three dimensions: temporality and future, positive readiness and expectancy, and social/spiritual connectedness [Farran, 1995]. This questionnaire has been translated and validated in French by Lafrance [2013].
Measured: changes of global score from baseline to 6-month post-intervention.
Secondary outcomes (5)
Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980].
The WCC French version contains 27 items quoted by Likert scales (answers within "no", "rather no", "rather yes", "yes"). Three specific dimensions are described:
- the focus on the problem
- the focus on emotions
- the search for social support Dimensions will be used separately using their scores as no global score can be calculated (dimensions are divergent). This questionnaire has been validated in French in 1996 by Bruchon-Schweitzer et al.
Measured: inclusion - 6-month post-intervention - 1-year post-intervention
Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973].
Perceived Control of IPC tests two locus of control: either in the self, or outside with two origins: fate/luck and "powerful others". Scores qualifying each locus of control will be used for statistics. This 24-item scale has been validated in French by Loas et al. [1994].
Measured: inclusion - 6-month post-intervention - 1-year post-intervention
Level of Anxiety, either fundamental (as a trait of character) or superficial (depending on circumstances) evaluated by the State and Trait Anxiety Inventory (STAI A-B) [Spielberger, 1983]
The STAI A-B questionnaire evaluates anxiety in a way it cannot be confused with depressive syndrome. It comprises 40 items rated on a 4-point scale from "almost never" to "almost always". The 20 first ones evaluate the anxiety as a state, that is a labile/contextual form. The last 20 items estimate anxiety as a personality trait, independent of the environment. It has been translated and validated in French by Schweitzer \& Paulhan [1990].
Measured: inclusion - 6-month post-intervention - 1-year post-intervention
Score of the Self-Esteem Scale (SES) [Rosenberg, 1965]
It is a short 10-item questionnaire that evaluates the global self-worth by questioning positive and negative feelings about the self. The uni-dimensionality of the scale has been validated [Gray-Little, 1997]. The global score of the scale will be used as an indicator of self-esteem.
Measured: inclusion - 6-month post-intervention - 1-year post-intervention
Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998].
This questionnaire is worldwidely used. It contains four main dimensions: physical health, psychological, social relationships and environment. These dimensions have been confirmed in the French version by Leplège et al. [2000]. The global QoL score (means of subscales) will also be used for statistics.
Measured: inclusion - 6-month post-intervention - 1-year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Why it stopped: COVID19 crisis prevents from organizing the last seminar
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hereditary Breast and Ovarian Cancer SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir et la MASFIP, Paris - France
- Responsible party
- Sponsor
- Investigators
- Yves-Jean BIGNON, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705924
- Sponsor's protocol ID
- BRACAVENIR
- Status last verified
- Nov 2021
- First submitted
- 2 Mar 2016
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: answers to questionnaires
Publications
Cousson-Gelie F, Cosnefroy O, Christophe V, Segrestan-Crouzet C, Merckaert I, Fournier E, Libert Y, Lafaye A, Razavi D. The Ways of Coping Checklist (WCC): validation in French-speaking cancer patients. J Health Psychol. 2010 Nov;15(8):1246-56. doi: 10.1177/1359105310364438. Epub 2010 Aug 27.
PubMed 20801945Bruchon-Schweitzer M, Cousson F, Quintard B, Nuissier J, Rascle N. French adaptation of the Ways of Coping Checklist. Percept Mot Skills. 1996 Aug;83(1):104-6. doi: 10.2466/pms.1996.83.1.104.
PubMed 8873181Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
PubMed 1430629Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. No abstract available.
PubMed 7410799Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973 Dec;41(3):397-404. doi: 10.1037/h0035357. No abstract available.
PubMed 4803272Loas G, Dardennes R, Dhee-Perot P, Leclerc V, Fremaux D. [Operationalization of the "locus of control" concept: translation and first validation study of the Levenson control scale (IPC: the internal powerful others and chance scale)]. Ann Med Psychol (Paris). 1994 Aug-Sep;152(7):466-9. French.
PubMed 7978779Power M, Harper A, Bullinger M. The World Health Organization WHOQOL-100: tests of the universality of Quality of Life in 15 different cultural groups worldwide. Health Psychol. 1999 Sep;18(5):495-505. doi: 10.1037//0278-6133.18.5.495.
PubMed 10519466Leplege A, Reveillere C, Ecosse E, Caria A, Riviere H. [Psychometric properties of a new instrument for evaluating quality of life, the WHOQOL-26, in a population of patients with neuromuscular diseases]. Encephale. 2000 Sep-Oct;26(5):13-22. French.
PubMed 11192800Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000 Dec;32(6):1431-41. doi: 10.1046/j.1365-2648.2000.01619.x.
PubMed 11136411Kwiatkowski F, Gay-Bellile M, Dessenne P, Laquet C, Boussion V, Beguinot M, Petit MF, Gremeau AS, Verlet C, Chaptal C, Broult M, Jouvency S, Duclos M, Bignon YJ. BRACAVENIR: an observational study of expectations and coping in young women with high hereditary risk of breast and ovarian cancer. Hered Cancer Clin Pract. 2019 Feb 27;17:7. doi: 10.1186/s13053-019-0107-7. eCollection 2019.
PubMed 30858899Kwiatkowski F, Dessenne P, Laquet C, Daures JP, Gay-Bellile M, Bignon YJ. BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial. Trials. 2016 Oct 21;17(1):509. doi: 10.1186/s13063-016-1642-4.
PubMed 27769293
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women (18-40 Years) Exposed to a High Familial Breast/Ovarian Cancer Risk
- ClinicalTrials.gov ID
- NCT02705924
- Acronym / sponsor ID
- BRACAVENIR
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 crisis prevents from organizing the last seminar
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir et la MASFIP, Paris - France
- Study start
- Apr 2016 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 11 Mar 2016 (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.
Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Unfortunately, these women face these issues at a key moment of there identity construction (self, relationship, sexuality) while they are not yet concerned by health prevention measures. A special psychoeducational intervention was designed to help these women to better cope with these difficulties.
Intervention consists in a week-end session in a thermal center (SPA) during which they will attend short conferences given by specialists (prevention measures, prophylactic surgery, assisted procreation, epidemiology...) and participate to role games and group sharing.
Intervention will be evaluated using self-questionnaires completed before intervention and during the following year.
Detailed description
Background: Young women exposed to a high hereditary breast/ovaries cancer (HBOC) risk are particularly vulnerable: they are ignored by health prevention measures; they are embedded in a stream of contradictory information ( medicine, media, internet); they may feel concerned by surgical prevention issues at a key moment of there identity construction (self, relationship, sexuality). A special psychoeducational intervention was designed to help these women to better cope with these difficulties.
Methods/design: the study consists in a prospective randomized trial including childless young female counselees (18-40 years) of CCC Jean Perrin oncogenetics department, belonging to HBOC families either BRCA-mutated or not. They will be invited to attend a weekend group session in a SPA resort and participate to a series of short expert conferences and to focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (waiting list) will enable us to evaluate the intervention effect, by comparing the evolution of questionnaires scores between inclusion and 6-month post-intervention. Main end-point is an increase of the Hert Hope Inventory of at least one standard deviation. Secondary endpoints investigate self-esteem, anxiety-trait, anxiety-state, ways of coping and quality of life. Participants will be randomized 1:1 to the first or the second session so that groups are comparable. Session will be cost-free for participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational intervention | Experimental | Behavioral: psychoeducationgroup participating to the first psychoeducational intervention: it consists in a week-end session in a SPA center including several conferences about HBOC familial risk, cancer prevention, prophylactic possibilities (surgery), recommendations about nutrition and physical activity a risk modulators, assisted medical procreation and embryo selection, social support...). Besides conferences, Moreno role games and group sharing are organized under the supervision of a psychotherapist. |
| Waiting list | Other | Behavioral: psychoeducationdelayed intervention: group participating to the second psychoeducational intervention (6 months later). Intervention is same as in the intervention arm but it is delayed. Because questionnaires are completed before this second intervention in both arms and allocation to arms are randomized, it represents an adequate control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must belong to HBOC families,
- aged between 18 and 40 years
- Single or couple with a desire to have a child
- without any personal history of cancer.
- must have consulted at the oncogenetics department of the CCC Jean Perrin
Key exclusion criteria (4 listed)
- pregnant women
- person who cannot answer questionnaires: language difficulties and/or cannot write in French correctly.
- no possible connection to our web-site
- psychiatric troubles and/or ongoing treatments preventing from a week-end stay in a SPA resort
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 |
|---|---|---|
| psychoeducationParticipants will attend conferences where experts present the state of the art in various domains: * Latest knowledge in oncogenetics * Recommendations and morbidity of prophylactic breast surgeries and annexectomy * Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits * How to perform the periodic breast screening * Assisted medical procreation and embryo selection * Importance of nutrition and physical activity as risk modulator * Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)? * Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening. The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist. | Behavioural | Psychoeducational intervention, Waiting list |
Primary outcome
changes in expectations measured using the Hert Hope Inventory questionnaire
Time frame: changes of global score from baseline to 6-month post-intervention.
Hert Hope Inventory global score [Herth, 1992, 2000] is used to evaluate expectations of participants. It contains only 12 simple proposals quoted using a 4-point Likert scale ranking from 1 = "strongly disagree" to 4 = "strongly agree". Its internal structure is composed of three dimensions: temporality and future, positive readiness and expectancy, and social/spiritual connectedness [Farran, 1995]. This questionnaire has been translated and validated in French by Lafrance [2013].
5 secondary outcomes
Dimensions of coping evaluated by the Ways of Coping Checklist (WCC) [Folkman, 1980].
Time frame: inclusion - 6-month post-intervention - 1-year post-intervention
Dimensions of perceived control measured using the Internal Powerful others and Chance scale (IPC) [Levenson, 1973].
Time frame: inclusion - 6-month post-intervention - 1-year post-intervention
Level of Anxiety, either fundamental (as a trait of character) or superficial (depending on circumstances) evaluated by the State and Trait Anxiety Inventory (STAI A-B) [Spielberger, 1983]
Time frame: inclusion - 6-month post-intervention - 1-year post-intervention
Score of the Self-Esteem Scale (SES) [Rosenberg, 1965]
Time frame: inclusion - 6-month post-intervention - 1-year post-intervention
Subscales and global score of the WHO Quality of life questionnaire ( World Health Organization WHOQOL) [Harper, 1998].
Time frame: inclusion - 6-month post-intervention - 1-year post-intervention
Results and safety
The study was stopped early (reason given: COVID19 crisis prevents from organizing the last seminar). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 20801945Cousson-Gelie F, Cosnefroy O, Christophe V, Segrestan-Crouzet C, Merckaert I, Fournier E, Libert Y, Lafaye A, Razavi D. The Ways of Coping Checklist (WCC): validation in French-speaking cancer patients. J Health Psychol. 2010 Nov;15(8):1246-56. doi: 10.1177/1359105310364438. Epub 2010 Aug 27.
- Background: PubMed 8873181Bruchon-Schweitzer M, Cousson F, Quintard B, Nuissier J, Rascle N. French adaptation of the Ways of Coping Checklist. Percept Mot Skills. 1996 Aug;83(1):104-6. doi: 10.2466/pms.1996.83.1.104.
- Background: PubMed 1430629Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
- Background: PubMed 7410799Folkman S, Lazarus RS. An analysis of coping in a middle-aged community sample. J Health Soc Behav. 1980 Sep;21(3):219-39. No abstract available.
- Background: PubMed 4803272Levenson H. Multidimensional locus of control in psychiatric patients. J Consult Clin Psychol. 1973 Dec;41(3):397-404. doi: 10.1037/h0035357. No abstract available.
- Background: PubMed 7978779Loas G, Dardennes R, Dhee-Perot P, Leclerc V, Fremaux D. [Operationalization of the "locus of control" concept: translation and first validation study of the Levenson control scale (IPC: the internal powerful others and chance scale)]. Ann Med Psychol (Paris). 1994 Aug-Sep;152(7):466-9. French.
- Background: PubMed 10519466Power M, Harper A, Bullinger M. The World Health Organization WHOQOL-100: tests of the universality of Quality of Life in 15 different cultural groups worldwide. Health Psychol. 1999 Sep;18(5):495-505. doi: 10.1037//0278-6133.18.5.495.
- Background: PubMed 11192800Leplege A, Reveillere C, Ecosse E, Caria A, Riviere H. [Psychometric properties of a new instrument for evaluating quality of life, the WHOQOL-26, in a population of patients with neuromuscular diseases]. Encephale. 2000 Sep-Oct;26(5):13-22. French.
- Results publication: PubMed 11136411Herth K. Enhancing hope in people with a first recurrence of cancer. J Adv Nurs. 2000 Dec;32(6):1431-41. doi: 10.1046/j.1365-2648.2000.01619.x.
- Derived from this study: PubMed 30858899Kwiatkowski F, Gay-Bellile M, Dessenne P, Laquet C, Boussion V, Beguinot M, Petit MF, Gremeau AS, Verlet C, Chaptal C, Broult M, Jouvency S, Duclos M, Bignon YJ. BRACAVENIR: an observational study of expectations and coping in young women with high hereditary risk of breast and ovarian cancer. Hered Cancer Clin Pract. 2019 Feb 27;17:7. doi: 10.1186/s13053-019-0107-7. eCollection 2019.
- Derived from this study: PubMed 27769293Kwiatkowski F, Dessenne P, Laquet C, Daures JP, Gay-Bellile M, Bignon YJ. BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial. Trials. 2016 Oct 21;17(1):509. doi: 10.1186/s13063-016-1642-4.
- Individual participant dataSharing planned: Undecided. answers to questionnaires
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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.
Yves-Jean BIGNON principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation in people with Hereditary Breast and Ovarian Cancer Syndrome, run by Centre Jean Perrin 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 9 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: stopped early, as of the sponsor's last update on 30 Nov 2021. 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 was stopped early (reason given: COVID19 crisis prevents from organizing the last seminar). 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?
changes in expectations measured using the Hert Hope Inventory questionnaire (time frame: changes of global score from baseline to 6-month post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02705924, which also lists 11 linked publications.
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 30 Nov 2021.