Breast CancerEdherenceNCT05324020
eHealth Intervention for Medication Adherence in Breast Cancer Survivors
A study testing Medication adherence eHealth intervention in people with Breast Cancer, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Medication adherence eHealth intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesLuxembourg
- Study dates
- 4 Oct 2021to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 1st prescription of adjuvant treatment (Nolvadex, Arimidex)
- Treated in either the Centre Hospitalier du Luxembourg (CHL) or Centre Hospitalier Emile Mayrisch (CHEM)
- Luxembourg resident
Show all 9Show fewer
- Fluent in French and/or German
- Outpatient
- Possession of a smart-phone (iOS, Android)
Who cannot join
- Male
- In situ or metastatic tumors
- Follow-up treatment outside of CHL or CHEM
- Non-Luxembourgish residents
- Inpatient
Trial locations and contacts
2 sites in 1 country.
Luxembourg2 sites
Centre Hospitalier Emile Mayrisch (CHEM)
Esch-sur-Alzette, L-4240
Centre Hospitalier de Luxembourg (CHL)
Luxembourg, L-1210
About this study
Official title: Improving Oral Hormonal Therapy Adherence in Breast Cancer Survivors by Using eHealth as a New Intervention Tool
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- Medication adherence eHealth intervention
- Keywords
- Breast cancer, Patient-physician communication, cancer survivor, eHealth, telemedicine, digital health, medication adherence, medication compliance
- Medical subject headings
- Breast Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication adherence eHealth interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Medication adherence eHealth intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 3 months
Secondary outcomes (4)
Breast Cancer nurses phone calls to patient
Number of phone calls to the patients
Measured: 3 months
Breast cancer nurse intervention
Capture of the type of intervention: Motivational; Strategic or Informational
Measured: 3 months
Quality of life is measured using the EORTC Quality of Life Questionnaire (QLQ C-30) questionnaire
The EORTC QLQ-C30 is a health related quality of life questionnaire specific for cancer patients. It has been translated and validated into French and German. The questionnaire is divided into five functional scales, three symptom scales, one global health/ quality of life scale and a number of single items assessing additional symptoms commonly reported by cancer patients. The functional scales, symptom scales, and single items assessing additional symptom have a 4-point scale whereas the global health/ quality of life scale has a 7-point scale. A high score in the functional scale represents a healthy level of functioning. A high score in the global health/ quality of life scale represents a good quality of life. A high score for the symptom scale represents a high level of symptomatology. The EORTC QLQ-C30 is evaluated at baseline and end of study.
Measured: through study completion, an average of 3 months
Beliefs about Medicine Questionnaire (BMQ)
The BMQ is an 18-item tool that assess the beliefs about treatment and has been translated and validated into French and German. The items are divided into specific treatment beliefs and general treatment beliefs the items have a 5 point Likert scale, ranging from 1 "strongly agree" to 5 "strongly disagree". For each, a total score was computed by adding together items' reverse scores. Each specific belief scores between 5 and 25, and each general belief between 4 and 20.Higher values represent stronger beliefs. The BMQ is evaluated at baseline and end of study.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start4 Oct 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier du Luxembourg, Centre Hospitalier Emile Mayrisch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324020
- Sponsor's protocol ID
- CNER 202107/05
- Acronym
- Edherence
- Status last verified
- Sep 2023
- First submitted
- 23 Feb 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oral Hormonal Therapy Adherence in Breast Cancer Survivors by Using eHealth as a New Intervention Tool
- ClinicalTrials.gov ID
- NCT05324020
- Acronym / sponsor ID
- Edherence / CNER 202107/05
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Patient-physician communication, cancer survivor, eHealth, telemedicine, digital health, medication adherence, medication compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Centre Hospitalier du Luxembourg, Centre Hospitalier Emile Mayrisch
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E- Health medication adherence Intervention group | Experimental | Behavioral: Medication adherence eHealth intervention3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 1st prescription of adjuvant treatment (Nolvadex, Arimidex)
- Treated in either the Centre Hospitalier du Luxembourg (CHL) or Centre Hospitalier Emile Mayrisch (CHEM)
Key exclusion criteria (5 listed)
- Male
- In situ or metastatic tumors
- Follow-up treatment outside of CHL or CHEM
- Non-Luxembourgish residents
- Inpatient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication adherence eHealth interventionThe 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). | Behavioural | E- Health medication adherence Intervention group |
Primary outcome
Acceptability of medication adherence support tool
Time frame: 3 months
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.
Quality of medication adherence support tool
Time frame: 3 months
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.
Medication Adherence
Time frame: 3 months
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
4 secondary outcomes
Breast Cancer nurses phone calls to patient
Time frame: 3 months
Breast cancer nurse intervention
Time frame: 3 months
Quality of life is measured using the EORTC Quality of Life Questionnaire (QLQ C-30) questionnaire
Time frame: through study completion, an average of 3 months
Beliefs about Medicine Questionnaire (BMQ)
Time frame: through study completion, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication adherence eHealth intervention in people with Breast Cancer, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of medication adherence support tool (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.