Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

Breast Cancer Clinical Trial

— AdOTAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435546
• Other study ID #: 2024-A00396-41
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: June 4, 2025

Study information

• Verified date: April 2024
• Source: Institut de Cancérologie de Lorraine
• Contact: Vincent Massard, MD
• Phone: +33383598461
• Email: v.massard[@]nancy.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 4, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Blood samples
Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin

Other:
• Adherence 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

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Identify if comorbitities is associated with reduced adherence to oral anticancer treatments	Comorbidities using the Charlson score (0 to 37).	one day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Describe and compare medication adherence to oral treatments	The correlation between the scores on the GIRERD and AdOT will be analysed.	one day
Secondary	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