An interventional study of Preparation in Self-Hypnosis by anchoring and Conversational Hypnosis in Breast Neoplasm Female, sponsored by Hospital St. Joseph, Marseille, France. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Hospital St. Joseph, Marseille, France · Not applicable, Interventional, and Other
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Among 1,208 studies in Breast Neoplasms with a site in France — 207 open to participants now, 342 under way, 83 of them phase 3. Breast Neoplasms · France.
Among the 1,208 studies in Breast Neoplasms with a site in France, this one is the 605th largest by planned enrollment of the 997 interventional ones that give a count, is one of 62 that started in 2022, is one of 339 with no phase, reaches primary completion later than 57 of the 341 other live ones, and was the 920th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →207 of the 1,208 studies in Breast Neoplasms with a site in France are open now. Recruiting first, the newest first:
Institut Claudius Regaud · Sites in France
Ages 66+ · Men only
Daiichi Sankyo · Sites in France, United States, Belgium and 5 more countries
Ages 18+
Centre Antoine Lacassagne · Sites in France
Ages 18–75
Institut Bergonié · Sites in France
Ages 15–49
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Ages 18+ · Women only
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,208 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 146 · Phase 2 324 · Phase 3 254 · Phase 4 17
First in 1990; this study’s year is marked. 62 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 150 across the 997 interventional studies, 200 across the 202 observational. Of the 787 that completed or were terminated, 254 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
449 of 1,208 have an industry lead sponsor. The 10 most frequent:
Hospital St. Joseph, Marseille, France is the lead sponsor of 31 studies on the registry; 4 are open to participants now.
Hospital St. Joseph, Marseille, France has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
80 of the studies in Breast Neoplasms with a site in France that are under way reach primary completion within a year, 19 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
Add all 80 to your calendar (.ics) → With an account.
Among the 1,208 studies in Breast Neoplasms with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.
Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.
Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.
Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.
However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
control
1-hour consultation with a hypnopractor just before the examination
Behavioral: Preparation in Self-Hypnosis by anchoring
conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
Behavioral: Conversational Hypnosis
1-hour consultation with a hypnopractor just before the examination and conversational hypnosis support during the examination by a radiology technician and a radiologist specifically trained
Behavioral: Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis
Preparation in Self-Hypnosis by anchoring just before examination
Conversational Hypnosis during examination
Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
change in anxiety score
Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment. Total scores can be categorized into five levels: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 35 (very low). Higher scores mean a worse outcome.
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
change in anxiety score
measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
change in pain score
measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)
Time frame: baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days
patient examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Time frame: baseline (immediately after the intervention)
staff examination experience
measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)
Time frame: baseline (immediately after the intervention)
anxiety score
STAI-Y2 (score from 20 to 80 measured on the STAI for trait anxiety), how respondent generally feel Total scores can be categorized into five levels: 1. \> 65 (very high), 2. from 56 to 65 (high), 3. from 46 to 55 (medium), 4. from 36 to 45 (low), 5. \< 35 (very low). Higher scores mean a worse outcome.
Time frame: baseline (pre-intervention)
Amount of nesthetic administered to the patiet during the procedure
mL
Time frame: baseline (immediately after the intervention)
Examination duration
minutes
Time frame: baseline (immediately after the intervention)
AE/SAE reporting
Time frame: baseline (during the intervention, immediatly after the intervetion) and at 8 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Dec 2024, 26 months after the start.
Of 2,662 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 26 months is below that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Hospital St. Joseph, Marseille, France