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Completed

NCT Number: NCT06435546

Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blood samples

Diagnostic Test

Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

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

Primary outcomes

  1. Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.

    Time frame: 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 outcomes

  1. Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments

    Time frame: one day

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

  2. Identify if comorbitities is associated with reduced adherence to oral anticancer treatments

    Time frame: one day

    Comorbidities using the Charlson score (0 to 37).

  3. 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

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

  4. Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments

    Time frame: one day

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

  5. Identify if biological markers are associated with reduced adherence to oral anticancer treatments

    Time frame: one day

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

  6. Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments

    Time frame: one day

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

  7. 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

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

  8. Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments

    Time frame: 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)

  9. Identify if HADS scale is associated with reduced adherence to oral anticancer treatments

    Time frame: 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)

  10. Identify if MNA is associated with reduced adherence to oral anticancer treatments

    Time frame: 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)

  11. 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

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

  12. Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.

    Time frame: 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).

  13. Study the relationship between the two adherence questionnaires.

    Time frame: 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).

  14. Describe and compare medication adherence to oral treatments

    Time frame: one day

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

  15. 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

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

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study title

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

Acronym: AdOTAC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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