Clinical trial NCT06435546: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
timeFrame: one day
Secondary outcomes:
measure: Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if comorbitities is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
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
timeFrame: one day
measure: Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if biological markers are associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if HADS scale is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if MNA is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments
timeFrame: one day
measure: Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
timeFrame: one day
measure: Study the relationship between the two adherence questionnaires.
timeFrame: one day
measure: Describe and compare medication adherence to oral treatments
timeFrame: one day
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.
timeFrame: one day
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Vincent Massard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cancérologie de Lorraine
name: Naoual Boujedaini, PhD
role: STUDY_CHAIR
References: