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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Female

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

    First Posted
    March 12, 2022
    Last Updated
    June 1, 2022
    Sponsor
    Ain Shams University
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    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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