E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.

NCT04228432 | Completed

• 1 other identifier: 19 SEIN 14
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy . 45 patients will be included. Patients will be followed during 6 months.

Conditions

Breast Cancer

Keywords

Breast Cancer; Hormonotherapy; E-monitoring

Outcome Measures

Primary Outcomes (1)

• Rate of patients who do not fail the E-Monitoring protocol

  6 months per patient

Secondary Outcomes (2)

• Number of medical consultations required over 6 months

  6 months per patient

• Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire

  6 months per patient

Study Arms (1)

Patients with breast cancer treated by adjuvant hormonotherapy

EXPERIMENTAL

Other: Dedicated and coordinated monitoring

Interventions

Dedicated and coordinated monitoring OTHER

* Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation * Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.

Patients with breast cancer treated by adjuvant hormonotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
• Patient equipped with a computer or tablet computer and an internet connection at home
• Age \> 18 years old
• Patient affiliated to the french social security system
• Women of childbearing age should have effective contraception under hormonotherapy

You may not qualify if:

• Patient with breast cancer who does not require adjuvant hormonotherapy
• Patient with metastatic breast cancer
• Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
• Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
• Patient protected by law.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 14, 2020
• Study Start: February 28, 2020
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

FR (1)