Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy

Real-time Tele-monitoring Versus Routine Monitoring of Breast Cancer Patients Receiving Adjuvant Systemic Therapy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: Tele-monitoring through mobile application

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Stage I-III breast cancer under adjuvant intravenous chemotherapy with or without targeted therapy.
2. Able to provide a written informed consent .
3. Must have an internet access.

Exclusion Criteria:

1. Presence of other malignancies whether in the past or simultaneously.
2. Male cancer patients.
3. Clinical diagnosis of Alzheimer's disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine monitoring; patients with breast cancer who will receive adjuvant treatment and will be followed up during treatment with routine visits.
Active Comparator: Tele-monitoring through mobile application; 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.	Other: Tele-monitoring through mobile application; Tele-monitoring of Patient reported outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
● 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.	3 years

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: March 12, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 261\2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No