Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

NCT06435546 | Completed

• 1 other identifier: 2024-A00396-41
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.

Conditions

Breast Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.

  Medication adherence to oral anticancer treatments will be assessed using a score based on the GIRERD adherence assessment (targeting oral anticancer treatments). The score is a scale ranging from 0 to 6 (good compliance = 6; poor compliance = 4 to 5; non-adherence ≤ 3).

  one day

Secondary Outcomes (15)

• Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments

  one day

• Identify if comorbitities is associated with reduced adherence to oral anticancer treatments

  one day

• Identify if polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications is associated with reduced adherence to oral anticancer treatments

  one day

• Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments

  one day

• Identify if biological markers are associated with reduced adherence to oral anticancer treatments

  one day

Study Arms (1)

Adherence oral anticancer therapies questionnaire

EXPERIMENTAL

Blood samples

Diagnostic Test: Blood samples; Other: Adherence to anti-cancer therapies questionnaires

Interventions

Blood samples DIAGNOSTIC_TEST

Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

Adherence oral anticancer therapies questionnaire

Adherence to anti-cancer therapies questionnaires OTHER

GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS

Adherence oral anticancer therapies questionnaire

Eligibility Criteria

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

You may qualify if:

• Adult over 18 years old.
• Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
• Oral anticancer medications started for at least 3 months.
• With a performance status ≤ 3.
• Patient has understood, signed and dated the consent form.
• Patient covered by the social security system.

You may not qualify if:

• Patient with early breast cancer or localized prostate cancer.
• Patient with life expectancy \< 3 months.
• Patient in progression
• Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
• Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
• Patient unable to read or speak French.
• Patient already included in another therapeutic trial with an experimental molecule.
• Persons deprived of their liberty or under guardianship (including curatorship).

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vincent Massard, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• Naoual Boujedaini, PhD

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: May 30, 2024
• Study Start: June 4, 2024
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

FR (1)