Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer

NCT04142476 | Terminated

• 1 other identifier: HORMONOVILLE
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the first cancer in women and 60% of new cases occurring in women 50 to 74 years old. With about 50,000 new cases, it is the second cancer the most serious cancers. In the therapeutic strategy, hormone therapy takes pride of place by allowing a significant reduction in the recurrence rate. For the hormonotherapy be effective, patient compliance should be optimal during treatment. Different factors or barriers may lead to a lack of adherence, such as the occurrence of adverse effects, treatment fatigue, a difficult relationship with the health care team, beliefs about success or the need for treatment. In order to facilitate the compliance of hormonoherapy treatment by patients, it is important to include different health professionals such as pharmacists.

Conditions

Breast Cancer

Keywords

Hormonotherpy; Compliance

Outcome Measures

Primary Outcomes (1)

• Patient compliance

  data from electronic pillboxes

  18 months

Study Arms (1)

Pharmaceutical Interview

EXPERIMENTAL

Pharmaceutical Interview to motivate patient in his hormonotherapy's compliance

Other: interview

Interventions

interview OTHER

interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.

Pharmaceutical Interview

Eligibility Criteria

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

You may qualify if:

• Woman, over 18 years old.
• With non-metastatic breast cancer.
• Treated by hormone therapy, regardless of the molecule (cancer RH positive).
• In primary prescription of hormone therapy.
• First prescription by a medical oncologist, surgeon or radiation therapist from the CGFL.
• Pharmacy of the patient located in the perimeter defined in the context of the study (Residents in the Burgundy region between a triangle delimited by the towns of Chatillon sur Seine, Dole and Chalon sur Saone.
• Woman who received information about the study and gave her written consent.
• Affiliation to a social security scheme.
• Participant Agreement of the referent city pharmacy of the patient.

You may not qualify if:

• Metastatic patient.
• Patient participating in another epidemiological or clinical study of adherence and / or hormone therapy.
• Patient under guardianship, curatorship or safeguard of justice.
• Patient with severe psychiatric disorders or who does not speak the French language
• Refusal to participate in the study.
• Refusal of participation of the referent city pharmacy of the patient.

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: June 25, 2019
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

FR (1)