Breast Cancer Clinical Trial
— USIMaPIOfficial title:
Multicenter Randomized Controlled Trial Evaluating the Effectiveness and Cost-effectiveness of the Use of Short Message Service (SMS) in the Screening Invitation Strategy for Breast Cancer.
Verified date | July 2019 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Each year in France, breast cancer affects about 48,000 women and is the first cause of
cancer death in women with 11,900 deaths estimated.
Since 2004, there is a national organized breast cancer screening (OBCS) programme for
asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer
screening department sends a personalized invitation mail to eligible women to perform a
mammogram and a breast clinical examination. One to two reminder mails are sent to women who
have not done the screening after an initial invitation. Despite this programme, almost 47%
of women in France do not participate to organized breast cancer screening.
The Short Message Service (SMS) is an innovative communication tool in the field of health,
immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative,
low-cost, personalized and ecological way to support the OBCS invitation strategy.
The overall objective of this study is to preserve or even better increase participation in
organized breast cancer screening while decreasing the associated costs by including SMS in
our screening invitation procedure.
Two SMS interventions will be tested which will correspond to different phases of the OBCS
invitation procedure. This sequence of interventions leads us to perform three interlinked
trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days
before the initial mail invitation), then two non-inferiority trials for the second phase (
two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the
first postal reminder).
Status | Completed |
Enrollment | 12000 |
Est. completion date | June 30, 2019 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 74 Years |
Eligibility |
Inclusion Criteria: - eligible to the organized breast cancer screening - residing in the region of Centre-Val de Loire (France) - Phone number registered in data bases of one of the 6 local cancer screening departments of the region of Centre-Val de Loire (France) Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
France | ADOC41 | Blois | |
France | ADOC28 | Chartres | |
France | CREDEP | Châteauroux | |
France | CCDC | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Compare the participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of sending an SMS before the invitation letter (vs sending the invitation letter alone = usual strategy). | For this first phase, the study aims to demonstrate that the addition of the SMS is superior in terms of participation and participation costs. | Before the sending time of the reminder 1 (letter or SMS) : from 3 months to 8 months after the invitation letter depending to periods of the concerned local cancer screening department | |
Primary | Phase 2: Compare participation rates in organized breast cancer screening (and the cost by screened woman) in response to a strategy of replacing the reminder 1 by mail with a reminder 1 by SMS ( reminder 1 mail = usual strategy). | For this second phase, the study aims to demonstrate the non-inferiority of the strategy including the SMS in terms of participation and cost-participation according to the two contexts: women who have already received an invitation letter alone. women who have already received one SMS and the invitation mail. |
Before the sending time of the reminder 2 : from 3 months to 6 months after the reminder 1 depending to periods of the concerned local cancer screening department |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Recruiting |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |