Adherence to Oral Therapies in Advanced Breast and Prostate Cancers (AdOTAC)

March 24, 2026 updated by: Institut de Cancérologie de Lorraine

Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adherence oral anticancer therapies questionnaire
Blood samples
Diagnostic test: Blood samples
Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin
Other: Adherence to anti-cancer therapies questionnaires
GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Time Frame: one day

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
The performance status by the ECOG-PS score (0 to 4).
one day
Identify if comorbitities is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Comorbidities using the Charlson score (0 to 37).
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
Time Frame: one day
Polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications (0 to >5).
one day
Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
The treatment regimen by a level of complexity (4 levels) given by an oncologist.
one day
Identify if biological markers are associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Biological markers (ferritin, TSAT, serum iron, haemoglobin, albumin) by a blood test.
one day
Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Sarcopenia by the body mass/fat mass ratio using imaging (SMI: skeletal muscle mass index).
one day
Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Quality of life using the EORTC-QLQ-C30 questionnaire score.
one day
Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Social and emotional support by the MSPSS questionnaire (Multidimensional Scale of Perceived Social Support) (12-35: low perceived support; 36-60: medium perceived support; 61-84: hugh perceived support)
one day
Identify if HADS scale is associated with reduced adherence to oral anticancer treatments
Time Frame: one day

Anxiety and/or depression using the Hospital Anxiety and Depression Scale (HADS).

(If the score in a column is greater than or equal to 11, it means person suffer from anxiety or depression)
one day
Identify if MNA is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Malnutrition using the MNA (Mini-Nutritional Assessment) questionnaire (24-30 points: normal nutritional status; 17-23.5 points: at risk of malnutrition; less than 17 points: malnourished)
one day
Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments
Time Frame: one day
Use of social networks and alternatives and complementary medicines using patient questionnaire developed specifically for the study population.
one day
Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
Time Frame: one day
Medication adherence to oral anticancer treatments will also be assessed using the score from the new AdOT questionnaire. The score is a scale ranging from 0 (no adherence) to 100 (perfect adherence).
one day
Study the relationship between the two adherence questionnaires.
Time Frame: one day
Subgroup analysis by cancer type (breast; prostate), use of alternatives and complementary medicines (yes; no) and use of social media and networks (yes; no).
one day
Describe and compare medication adherence to oral treatments
Time Frame: one day
The correlation between the scores on the GIRERD and AdOT will be analysed.
one day
Describe and compare patient characteristics (socio-demographic, clinical and contextual), medication adherence to oral anticancer treatments according to cancer type, use of alternative and complementary medicines and use of social media and networks.
Time Frame: one day
Subgroup analysis by cancer type (breast; prostate), use of alternative and complementary medicines (yes; no) and use of social media and networks (yes; no).
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Cancérologie de Lorraine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Naoual Boujedaini, PhD, Institut de Cancérologie de Lorraine
  • Principal Investigator: Vincent Massard, MD, Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-A00396-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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