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NCT Number: NCT06726889

Increasing Oral Medication Adherence for Metastatic Breast Cancer Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, 20141, Italy

Location status: Recruiting

Location contact

Gabriella Pravettoni, MD

CONTACT

[email protected]

+39 0257489731

About this study

Today different types of Oral Anticancer Agents (OAA) are commonly prescribed to Breast Cancer (BC) patients. Patients are reported to prefer the oral modality of administration over the intravenous one for its convenience, flexibility, and easier assumption; nonetheless, the phenomenon of medication non-adherence is well-documented.

Although several interventions have been designed and tested in order to foster medication adherence among BC patients, the great majority of them were focused on adherence to endocrine therapy for early-stage BC patients, with only few exceptions involving metastatic BC patients or considering adherence to other types of OAA.

The aim of this work is to optimize an adherence increasing intervention designed for metastatic BC patients. This will be achieved by applying a full factorial design in order to evaluate the optimal combination of three different intervention components (informative documentation, personalized reminders and feedback).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Standard Care

Behavioral

Patient will not receive any additional interventions

Decision Support System (DSS)

Behavioral

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

Reminders

Behavioral

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

Feedback

Behavioral

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

Primary outcomes

  1. Adherence to oral medication

    Time frame: 7 months

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

Secondary outcomes

  1. Depressive symptoms evaluation

    Time frame: 7 months

    Collection of Beck Depression Inventory II (BDI-II) questionnaire (minimum value: 0, maximum value: 3 - higher scores mean greater depression)

  2. Anxiety evaluation

    Time frame: 7 months

    Collection of State-Trait Anxiety Inventory (STAI) questionnaire (minimum value: 1, maximum value: 4 - higher scores signify greater anxiety)

  3. Quality of life evaluation

    Time frame: 7 months

    Completion of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC-QLQ-C30 (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)

  4. Health-related quality of life evaluation

    Time frame: 7 months

    Completion of European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC-QLQ-BR23) (minimum value: 1, maximum value: 4 - higher scores mean a greater agreement with the statement)

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Pravettoni, MD

CONTACT

[email protected]

+39 0257489731

Mara Negri

CONTACT

[email protected]

+39 0257489536

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Optimizing an Intervention to Increase Oral Medication Adherence for Metastatic Breast Cancer Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 20, 2024

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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