## Protocol Section
### Identification Module
**NCT ID:** NCT06435546

**Acronym:** AdOTAC

**Brief Title:** Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

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

#### Organization Study ID Info
**ID:** 2024-A00396-41
#### Organization
**Class:** OTHER
**Full Name:** Institut de Cancérologie de Lorraine
### Status Module
#### Completion Date
**Date:** 2025-08-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-24

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-27
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut de Cancérologie de Lorraine

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Breast Cancer

- Prostate Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Blood samples

**Intervention Names:**

- Diagnostic Test: Blood samples

- Other: Adherence to anti-cancer therapies questionnaires

**Label:** Adherence oral anticancer therapies questionnaire

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Adherence oral anticancer therapies questionnaire

**Description:** Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

**Name:** Blood samples

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Adherence oral anticancer therapies questionnaire

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

**Name:** Adherence to anti-cancer therapies questionnaires

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**Measure:** Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.

**Time Frame:** one day

#### Secondary Outcomes

**Description:** The performance status by the ECOG-PS score (0 to 4).

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

**Time Frame:** one day

**Description:** Comorbidities using the Charlson score (0 to 37).

**Measure:** Identify if comorbitities is associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** Polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications (0 to \>5).

**Measure:** 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

**Description:** The treatment regimen by a level of complexity (4 levels) given by an oncologist.

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

**Time Frame:** one day

**Description:** Biological markers (ferritin, TSAT, serum iron, haemoglobin, albumin) by a blood test.

**Measure:** Identify if biological markers are associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** Sarcopenia by the body mass/fat mass ratio using imaging (SMI: skeletal muscle mass index).

**Measure:** Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** Quality of life using the EORTC-QLQ-C30 questionnaire score.

**Measure:** 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

**Description:** 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)

**Measure:** Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** 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)

**Measure:** Identify if HADS scale is associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** 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)

**Measure:** Identify if MNA is associated with reduced adherence to oral anticancer treatments

**Time Frame:** one day

**Description:** Use of social networks and alternatives and complementary medicines using patient questionnaire developed specifically for the study population.

**Measure:** 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

**Description:** 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).

**Measure:** Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.

**Time Frame:** one day

**Description:** Subgroup analysis by cancer type (breast; prostate), use of alternatives and complementary medicines (yes; no) and use of social media and networks (yes; no).

**Measure:** Study the relationship between the two adherence questionnaires.

**Time Frame:** one day

**Description:** The correlation between the scores on the GIRERD and AdOT will be analysed.

**Measure:** Describe and compare medication adherence to oral treatments

**Time Frame:** one day

**Description:** Subgroup analysis by cancer type (breast; prostate), use of alternative and complementary medicines (yes; no) and use of social media and networks (yes; no).

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** 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).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** v.massard@nancy.unicancer.fr

**Name:** Vincent Massard, MD

**Phone:** +33383598461

**Role:** CONTACT

**Contact 2:**

**Email:** jl.merlin@nancy.unicancer.fr

**Name:** Jean-Louis Merlin, Pr

**Phone:** +33383656062

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vandœuvre-lès-Nancy

**Country:** France

**Facility:** Institut de Cancerologie de Lorraine

#### Overall Officials

**Official 1:**

**Affiliation:** Institut de Cancérologie de Lorraine

**Name:** Vincent Massard, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Institut de Cancérologie de Lorraine

**Name:** Naoual Boujedaini, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M207501

- Name: Chrysarobin

- Relevance: LOW

- As Found: Unknown

- ID: M10533

- Name: Iron

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
