RecruitingNot ApplicableNCT06435546

Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

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


Sponsor

Institut de Cancérologie de Lorraine

Enrollment

200 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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).

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


Locations(1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

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NCT06435546


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