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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adherence oral anticancer therapies questionnaire | Experimental | Blood samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Diagnostic Test | Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Massard, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Naoual Boujedaini, PhD | Institut de Cancérologie de Lorraine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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 | 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. | 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |