Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05401942 |
| Other study ID # |
261\2021 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2022 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
June 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
