Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy
Primary Purpose
Breast Cancer Female
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tele-monitoring through mobile application
Sponsored by

About this trial
This is an interventional health services research trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
- Stage I-III breast cancer under adjuvant intravenous chemotherapy with or without targeted therapy.
- Able to provide a written informed consent .
- Must have an internet access.
Exclusion Criteria:
- Presence of other malignancies whether in the past or simultaneously.
- Male cancer patients.
- Clinical diagnosis of Alzheimer's disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Routine monitoring
Tele-monitoring through mobile application
Arm Description
patients with breast cancer who will receive adjuvant treatment and will be followed up during treatment with routine visits.
Patients with breast cancer who will receive adjuvant therapy and will be followed up during treatment through tele-monitoring with mobile application and CTCAE checklist for PRO.
Outcomes
Primary Outcome Measures
Comparison of frequency and severity of symptoms using real-time tele-monitoring versus routine symptom monitoring.
To compare between grade of side effects of treatment between both arms through CTCAE checklist for patient reported outcomes.
Secondary Outcome Measures
● Comparison of adherence to treatment between both groups.
to compare the tolerability for treatment between both arms through assessment of the percentage of dose delay in both groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05401942
Brief Title
Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy
Official Title
Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with breast cancer receiving systemic therapy have a variety of symptoms.
In cancer patients receiving chemotherapy and targeted therapy, it is common to report symptoms to physicians before each cycle of systemic therapy and planning maintenance and treatment applications accordingly. Nowadays tele-monitoring of patient reported outcomes using mobile applications is used widely.
These applications provide many advantages to the patient, physicians, and health care system because patients report the symptoms experienced and helps contribute to the quick management of the symptoms and improve the adherence to treatment, decrease the frequency of dose delays and dose reduction of their treatment.
Detailed Description
In Egypt, breast cancer is the most frequent malignancy among Egyptian women, accounting for 38.8% of cancers in this population, with the expected number of breast cancer cases nearly 22, 700 in 2020 and forecasted to be approximately 46, 000 in 2050.It is found that the breast cancer mortality rate is around 11%, being the second cause of cancer-related mortality after hepatocellular carcinoma.
Systemic therapy including chemotherapy and antiHER2 drugs are frequently utilized in the adjuvant setting in the treatment of breast cancer as Anthracycline-based chemotherapy (AC, FEC, FAC Protocols containing Doxorubicin, Epirubicin, fluorouracil and cyclophosphamide), which may lead to cardiac side effects, taxanes (Paclitaxel and Docetaxel) which may lead to GIT Problems and peripheral neuropathy. The addition of trastuzumab to a sequential anthracycline/cyclophosphamide-taxane regimen was linked to a 3% risk of cardiac toxicity, whereas trastuzumab in conjunction with non-anthracycline regimens (e.g. carboplatin/docetaxel) was linked to lower rates of cardiac toxicity.
These drugs may result in a variety of symptoms to develop, it is critical to measure, prevent and control them. Patient-reported outcomes (PROs) are becoming more popular as a way to quantify symptoms and health-related quality of life in cancer care. PROs are useful to capture the patient's perspective on their care and treatment, and they are intended to supplement traditional clinical outcomes and toxicity reported by physicians such as survival and toxicity assessment.
Tele-monitoring is crucial in patients' follow-up as it will improve patients' adherence to treatment, decrease the frequency in dose reduction and dose delay. This will be accomplished by using tele-monitoring in reporting and managing patient reported outcomes from chemotherapy using PRO- CTCAE Checklist, version 1 to assess the grade and severity of symptoms reported by patients throughout the course of adjuvant chemotherapy with early management compared to the routine monitoring done in the regular clinic visits. In order to avoid the complications, symptoms should be diagnosed early and symptom referral for management should be advised and offered with evidence-based approaches. For this purpose, symptom reporting has recently been using mobile applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine monitoring
Arm Type
No Intervention
Arm Description
patients with breast cancer who will receive adjuvant treatment and will be followed up during treatment with routine visits.
Arm Title
Tele-monitoring through mobile application
Arm Type
Active Comparator
Arm Description
Patients with breast cancer who will receive adjuvant therapy and will be followed up during treatment through tele-monitoring with mobile application and CTCAE checklist for PRO.
Intervention Type
Other
Intervention Name(s)
Tele-monitoring through mobile application
Intervention Description
Tele-monitoring of Patient reported outcomes
Primary Outcome Measure Information:
Title
Comparison of frequency and severity of symptoms using real-time tele-monitoring versus routine symptom monitoring.
Description
To compare between grade of side effects of treatment between both arms through CTCAE checklist for patient reported outcomes.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
● Comparison of adherence to treatment between both groups.
Description
to compare the tolerability for treatment between both arms through assessment of the percentage of dose delay in both groups.
Time Frame
3 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage I-III breast cancer under adjuvant intravenous chemotherapy with or without targeted therapy.
Able to provide a written informed consent .
Must have an internet access.
Exclusion Criteria:
Presence of other malignancies whether in the past or simultaneously.
Male cancer patients.
Clinical diagnosis of Alzheimer's disease.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34088557
Citation
Ozturk ES, Kutluturkan S. The Effect of the Mobile Application-Based Symptom Monitoring Process on the Symptom Control and Quality of Life in Breast Cancer Patients. Semin Oncol Nurs. 2021 Jun;37(3):151161. doi: 10.1016/j.soncn.2021.151161. Epub 2021 Jun 2.
Results Reference
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Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy
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