Breast Cancer, Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTBlood samples
Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin
OTHERAdherence 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
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments | one day | The performance status by the ECOG-PS score (0 to 4). |
| Identify if comorbitities is associated with reduced adherence to oral anticancer treatments | one day | Comorbidities using the Charlson score (0 to 37). |
| 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 | Polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications (0 to \>5). |
| Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments | one day | The treatment regimen by a level of complexity (4 levels) given by an oncologist. |
| Identify if biological markers are associated with reduced adherence to oral anticancer treatments | one day | Biological markers (ferritin, TSAT, serum iron, haemoglobin, albumin) by a blood test. |
| Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments | one day | Sarcopenia by the body mass/fat mass ratio using imaging (SMI: skeletal muscle mass index). |
| Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments | one day | Quality of life using the EORTC-QLQ-C30 questionnaire score. |
| Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments | 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) |
| Identify if HADS scale is associated with reduced adherence to oral anticancer treatments | 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) |
| Identify if MNA is associated with reduced adherence to oral anticancer treatments | 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) |
| Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments | one day | Use of social networks and alternatives and complementary medicines using patient questionnaire developed specifically for the study population. |
| Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer. | 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). |
| Study the relationship between the two adherence questionnaires. | 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). |
| Describe and compare medication adherence to oral treatments | one day | The correlation between the scores on the GIRERD and AdOT will be analysed. |
| 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. | 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). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVincent Massard, MD
Institut de Cancérologie de Lorraine
STUDY_CHAIRNaoual Boujedaini, PhD
Institut de Cancérologie de Lorraine
Outcome results
None listed