Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

NCT06726889 | Recruiting

• 1 other identifier: IEO 2014
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to optimize an adherence increasing intervention designed for metastatic Breast Cancer (BC) patients by applying a full factorial design in order to evaluate the optimal combination of three different intervention components.

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer; Oral Anticancer Agents; Oral Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Adherence to oral medication

  Adherence rates will be evaluated as the percentage of doses correctly assumed compared to the total prescribed

  7 months

Secondary Outcomes (4)

• Depressive symptoms evaluation

  7 months

• Anxiety evaluation

  7 months

• Quality of life evaluation

  7 months

• Health-related quality of life evaluation

  7 months

Study Arms (8)

Standard Care + DSS + Reminders + Feedback

Patients will receive educational material through a web-page, personalized reminders and feedback messages by physician

Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Reminders; Behavioral: Feedback

Standard Care + DSS + Reminders

Patients will receive educational material through a web-page and personalized reminders

Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Reminders

Standard Care + DSS + Feedback

Patients will receive educational material through a web-page and feedback messages by physician

Behavioral: Standard care; Behavioral: Decision Support System (DSS); Behavioral: Feedback

Standard Care + DSS

Patients will receive educational material through a web-page

Behavioral: Standard care; Behavioral: Decision Support System (DSS)

Standard Care + Reminders + Feedback

Patients will receive personalized reminders and feedback messages by physician

Behavioral: Standard care; Behavioral: Reminders; Behavioral: Feedback

Standard Care + Reminders

Patients will receive personalized reminders

Behavioral: Standard care; Behavioral: Reminders

Standard Care + Feedback

Patients will receive feedback messages by physician

Behavioral: Standard care; Behavioral: Feedback

Standard Care

Patient will not receive any additional interventions

Behavioral: Standard care

Interventions

Standard care BEHAVIORAL

Patient will not receive any additional interventions

Standard Care; Standard Care + DSS; Standard Care + DSS + Feedback; Standard Care + DSS + Reminders; Standard Care + DSS + Reminders + Feedback; Standard Care + Feedback; Standard Care + Reminders; Standard Care + Reminders + Feedback

Decision Support System (DSS) BEHAVIORAL

DSS will be used to deliver educational material through a web-page (in Italian language) accessible through a link

Standard Care + DSS; Standard Care + DSS + Feedback; Standard Care + DSS + Reminders; Standard Care + DSS + Reminders + Feedback

Reminders BEHAVIORAL

Personalized reminders will be delivered to patients through a common messaging application (WhatsApp)

Standard Care + DSS + Reminders; Standard Care + DSS + Reminders + Feedback; Standard Care + Reminders; Standard Care + Reminders + Feedback

Feedback BEHAVIORAL

Feedback message will be delivered by physician to patients, through WhatsApp, after medication diary revision

Standard Care + DSS + Feedback; Standard Care + DSS + Reminders + Feedback; Standard Care + Feedback; Standard Care + Reminders + Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Metastatic breast cancer patients with a prescription for any Oral Anticancer Agent

You may qualify if:

• Patients with a diagnosis of metastatic BC
• Patients with a prescription for any OAA (i.e. oral chemotherapy, endocrine therapy, and Cyclin-Dependent Kinase 4/6 Inhibitors)
• Age \>18 years old
• Patients with a personal smart phone with internet access
• Willingness and ability to comply with scheduled visits and other trial procedures
• Understanding and speaking Italian language
• Written informed consent

You may not qualify if:

• Psychiatric disorders or conditions that might impair the ability to give informed consent
• Comorbidity that may impact on compliance to study procedures

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gabriella Pravettoni, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni, MD

CONTACT

+39 0257489731; gabriella.pravettoni@ieo.it

Mara Negri

CONTACT

+39 0257489536; mara.negri@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 25, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-11

Locations

IT (1)