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

NCT05401942 | Unknown DMC

• 1 other identifier: 261\2021
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ● Comparison of adherence to treatment between both groups.

  3 years

Study Arms (2)

Routine monitoring

NO INTERVENTION

patients with breast cancer who will receive adjuvant treatment and will be followed up during treatment with routine visits.

Tele-monitoring through mobile application

ACTIVE COMPARATOR

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

Interventions

Tele-monitoring through mobile application OTHER

Tele-monitoring of Patient reported outcomes

Tele-monitoring through mobile application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• 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.

  PMID: 34088557 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share