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Completed

NCT Number: NCT04228432

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

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
  • Women of childbearing age should have effective contraception under hormonotherapy

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 months per patient

Secondary outcomes

  1. Number of medical consultations required over 6 months

    Time frame: 6 months per patient

  2. Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire

    Time frame: 6 months per patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study title

E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study

Acronym: EPOPEE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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