Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Central Nervous System Stimulants

All Drugs and Chemicals

Other Dietary Supplements

Caffeine

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.

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).

Medication adherence eHealth intervention

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.

eHealth Intervention for Medication Adherence in Breast Cancer Survivors

Improving Oral Hormonal Therapy Adherence in Breast Cancer Survivors by Using eHealth as a New Intervention 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.

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.

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

Capture of the type of intervention: Motivational; Strategic or Informational

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.

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.

Centre Hospitalier du Luxembourg

Centre Hospitalier Emile Mayrisch

Luxembourg Institute of Health

Skin Neoplasms

Dermatologic Agents

Sunscreening Agents

The control or placebo comparator group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.

The text message experimental group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.

Electronic monitor is attached but no text-messages are sent through cellular phones

Electronic + no text message

Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use

Electronic monitor + text messages

Alexa B Kimball, MD MPH

April W Armstrong, MD

The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:

1. To determine whether the use of electronic reminder system increases adherence to topical agents.
2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
4. To obtain subjects' feedback on the adherence monitoring and reminder system.

We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.

Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use

Participants' adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.

Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)

The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)

Brigham and Women's Hospital

Massachusetts General Hospital

Principal Investigator

The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.

Control: Electronic Monitor+ no Text Message

The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.

Electronic Monitor + Text Message

Total

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Alexa B. Kimball

Number of Days the Subjects Are Adherent to Using Sunscreen

Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)

Usefulness of Text Messaging System

Patients with text messaging system included in analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
eHealth Intervention for Medication Adherence in Breast Cancer Survivors	NCT05324020	Breast Cancer	Medication adhe...	18 Years -	Luxembourg Institute of Health
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use	NCT00535769	Skin Cancer	Electronic + no... Electronic moni...	18 Years -	Massachusetts General Hospital
eHealth Intervention for Medication Adherence in Breast Cancer Survivors	NCT05324020	Breast Cancer	Medication adhe...	18 Years -	Luxembourg Institute of Health
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use	NCT00535769	Skin Cancer	Electronic + no... Electronic moni...	18 Years -	Massachusetts General Hospital
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use	NCT00535769	Skin Cancer	Electronic + no... Electronic moni...	18 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for medication compliance