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临床试验/NCT05324020
NCT05324020已完成不适用

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

Luxembourg Institute of Health4 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
4
主要终点
Acceptability of medication adherence support tool

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • Fluent in French and/or German
  • Outpatient
  • Possession of a smart-phone (iOS, Android)

排除标准

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

结局指标

主要结局

Acceptability of medication adherence support tool

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Breast cancer nurse intervention(3 months)
  • Breast Cancer nurses phone calls to patient(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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

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