NCT05743686

App for Adverse Events to Oral Chemotherapy - Pilot Study

Completed NA Last updated 18 March 2026

What this trial tests

NA trial testing Application in Breast Neoplasms in 28 participants. Completed in 31 December 2025.

Timeline

16 January 2023

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	Julie Lemieux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	28
Start date	16 January 2023
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across Canada

Drugs / interventions tested

• Application

Conditions studied

• Breast Neoplasms — all drugs for Breast Neoplasms →
• Chemotherapeutic Toxicity — all drugs for Chemotherapeutic Toxicity →

Sponsor

Julie Lemieux

Who can join

18 and older, female only, with Breast Neoplasms or Chemotherapeutic Toxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, the treatment paradigm for hormone receptor positive, HER2-negative disease has shifted from "chemotherapy for visceral disease" and "hormone therapy for bone disease" to "chemotherapy only for visceral crises or endocrine resistance". In recent years, CDK4/6 inhibitors have been added to the therapeutic arsenal. A meta-analysis of clinical trials of first-line metastatic CDK4/6 inhibitors showed an improvement in progression-free survival but an increase in toxicities compared to endocrine therapy alone. Other commonly used oral therapies for breast cancer are mTOR inhibitors and capecitabine. Other oral molecules will be added to the therapeutic arsenal in the coming years (e.g. alpelisib and tucatinib), each with specific toxicities.

Newer targeted therapies given in combination with endocrine therapies for breast cancer (eg with palbociclib, everolimus, and capecitabine) pose a challenge to health care providers because they are oral drugs. For "traditional" intravenous chemotherapy, patients must go to the hospital regularly, which allows close care by a team of doctors, pharmacists and nurses dedicated to breast cancer. On the other hand, for oral agents, monitoring is less systematic. Monitoring and managing the toxicities of oral treatments becomes a challenge. Suboptimal management of side effects can compromise patients' adherence to their treatment, have a negative impact on their side effects and increase costs for the healthcare system. Systematic follow-up is therefore necessary.

In the information age, public access to the Internet is increasing and most households in the province of Quebec now have access to the Internet, either on a smart phone, tablet or computer. Recent studies have shown that having a system to "self-report" side effects could even improve the survival of cancer patients and reduce costs. Apps allow patients to take an active role in their healthcare.

With the availability of an increasing number of oral therapies, monitoring the toxicities experienced by these patients is becoming a challenge and oncology teams need tools to help them ensure patient safety. At the same time, patients clearly want more information. The potential benefits and ease of use of web interfaces and patient portals for the management of oral therapy toxicities are appealing, but there is a lack of studies on them.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Evaluation of a Web-Based App for Adverse Effect Management in Breast Cancer Patients Treated with Oral Targeted Therapy or Chemotherapy: Findings from a Pilot Study.
   Lemieux J, Côté I, Lemay M, Lauzier S, et al · · 2026 · PMID 42187589 · DOI 10.3390/curroncol33050272