NCT05324020

Brief Summary

Tamoxifen and aromatase inhibitors are two oral hormonal therapies (OHT) that decrease the risk of breast cancer recurrence by over 30 %. Their efficacy however strongly depends on the duration of use (5 to 10 years). Earlier work demonstrated that the longer an individual is not taking her OHT the less likely she is to restart her therapy. Thus, identifying the moment of treatment interruption in real-time and being able to contact the patient at these specific time-points may be the key to effective health interventions by improving medication adherence to reduce BC recurrence - therefore, increasing overall Breast Cancer survival (BCS). EHealth technologies may be a very effective mean to identify these interruptions in a real-time manner and to provide support at the time the person needs it. The overall aim of the E-dherence Pilot study is to evaluate the feasibility of the E-Health intervention to enhance OHT adherence in BCS. Feasibility is defined based on 1.The eHealth intervention acceptability, 2. eHealth intervention quality and 3. medication adherence. The study will include female breast cancer starting their first prescription of tamoxifen or aromatase inhibitors and are outpatient and followed-up in either of the 2 study sites. Participants should be 18 years or older and be fluent in french and or German and possess a smart-phone (iOS, Android). The investigators exclude males, patients with in situ metastatic tumors, inpatients and non Luxembourg residents. Within the E-dherence Pilot study each patient receives the eHealth intervention. The eHealth intervention consists a Medication Event Monitoring Systems (MEMS®) Helping Hand and MEMS Adherence Software application. The eHealth intervention will support BCS to adhere to the recommended OHT (i) by alerting the participants to take their OHT, and (ii) by allowing patient-physician communication. The intervention consists of a Medication Event Monitoring Systems (MEMS®), an electronic pillbox that counts the OHT intake, the date and time. Through Near Field Communication (NFC) the device is connected to the MEMS Adherence Software application on the patients' phone (Android or iOS). At the beginning, each patient can personalize the application. This application registers the history of OHT adherence (time and date of medication intake) and sends reminders to the patient to take the treatment as scheduled. Additionally, the patient receives an integrated calendar in the App that notifies the patient for upcoming medical visits. The eHealth intervention comprises a questionnaire that should be filled-out weekly and that informs about the presence and severity of side effects. These data are collected in real-time and monitored on a weekly basis by the clinical research nurse (CRN) in charge of the study. In case of an alert, meaning recurrent non-adherence and/or reporting of side-effects, the CRN will contact the breast cancer nurse (BCN) in charge of the patient. Thus the BCN will contact the patient by phone to check on their health status and together define the future procedure in order for the patient to remain on OHT and/or to better manage their side-effects. In a worst case scenario, the BCN will refer the patient to see the emergency department and/or the oncologist. The study received all ethical approvals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

February 23, 2022

Last Update Submit

September 6, 2023

Conditions

Breast Cancer

Keywords

Breast cancerPatient-physician communicationcancer survivoreHealthtelemedicinedigital healthmedication adherencemedication compliance

Outcome Measures

Primary Outcomes (3)

  • Acceptability of medication adherence support tool

    Proportion of patients that fully adhere to the eHealth intervention(MARS). The uMARS is a 23-item questionnaire divided into quality subscales and subjective quality. The questionnaire entails a section about the Perceived impact the eHealth application has on medication adherence. Medication adherence will be measured through the MEMS® Helping Hand that is connected to the MEMS Adherence Software application. Side-effects reporting are measured through a weekly questionnaire within the MEMS Adherence Software application.

    3 months

  • Quality of medication adherence support tool

    user Mobile Application Rating Scale (uMARS): The uMARS is a 23-item questionnaire divided into quality subscales ((a) engagement, (b) functionality, (c) aesthetics and (d) information) and subjective quality. Also, the questionnaire entails a section about the Perceived impact the eHealth application has on medication adherence. The items are scored based on a 5 point scale.

    3 months

  • Medication Adherence

    Proportion of days covered by medication intake during 3-months of follow-up. This outcome is measured with the Medication Event Monitoring Systems (MEMS®) Helping Hand and MEMS Adherence Software application

    3 months

Secondary Outcomes (4)

  • Breast Cancer nurses phone calls to patient

    3 months

  • Breast cancer nurse intervention

    3 months

  • Quality of life is measured using the EORTC Quality of Life Questionnaire (QLQ C-30) questionnaire

    through study completion, an average of 3 months

  • Beliefs about Medicine Questionnaire (BMQ)

    through study completion, an average of 3 months

Study Arms (1)

E- Health medication adherence Intervention group

EXPERIMENTAL

3 Month monitoring adherence and side-effect management using an eHealth intervention . Participants are in contact with there clinical care team which intervene in cases of non-adherence and/or side-effect reporting.

Behavioral: Medication adherence eHealth intervention

Interventions

Medication adherence eHealth interventionBEHAVIORAL

The eHealth intervention consists a Medication Event Monitoring Systems (MEMS®) Helping Hand and MEMS Adherence Software application. The eHealth intervention will support BCS to adhere to their OHT (i) by alerting them to take their OHT, and (ii) by allowing patient-physician communication. The eHealth intervention comprises a questionnaire that should be filled-out weekly and that informs about the presence and severity of side effects. These data are collected in real-time and monitored on a weekly basis by the clinical research nurse (CRN) in charge of the study. In case of an alert, meaning recurrent non-adherence and/or reporting of side-effects, the CRN will contact the breast cancer nurse (BCN) in charge of the patient. Thus the BCN will contact the patient by phone to check on their health status and together define the future procedures (behavioral strategies).

E- Health medication adherence Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Female aged ≥18 years old
  • st prescription of adjuvant treatment (Nolvadex, Arimidex)
  • Treated in either the Centre Hospitalier du Luxembourg (CHL) or Centre Hospitalier Emile Mayrisch (CHEM)
  • Luxembourg resident
  • Fluent in French and/or German
  • Outpatient
  • Possession of a smart-phone (iOS, Android)

You may not qualify if:

  • Male
  • In situ or metastatic tumors
  • Follow-up treatment outside of CHL or CHEM
  • Non-Luxembourgish residents
  • Inpatient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Emile Mayrisch (CHEM)

Esch-sur-Alzette, L-4240, Luxembourg

Location

Centre Hospitalier de Luxembourg (CHL)

Luxembourg, L-1210, Luxembourg

Location

MeSH Terms

Conditions

Breast NeoplasmsMedication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 12, 2022

Study Start

October 4, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

LU(2)