AzTrials
AzTrials

Breast NeoplasmsNCT05743686

App for Adverse Events to Oral Chemotherapy - Pilot Study

A study testing Application in people with Breast Neoplasms and Chemotherapeutic Toxicity, run by Julie Lemieux at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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". Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms, Chemotherapeutic Toxicity
What is being tested?
Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteCanada
Study dates
16 Jan 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >=18 years of age
  • metastatic breast cancer
  • receiving oral chemotherapy (palbociclib, everolimus, or capecitabine)
  • possess an smartphone, a tablet, or a personal compiter

Who cannot join

  • cognitive impairments

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St-Sacrement Hospital

    Québec, Quebec, G1S4L8

Other trials in Canada

About this study

Official title: Pilot Study of the Use of an App for the Follow-up of Oral Chemotherapy in Breast Cancer Patients

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.

Read more

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.

Being tested
Application
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApplicationDevice

    The participants will have access to an app allowing them to report their adverse effects to oral chemotherapy. Basic advices will be given and the hospital pharmacists will be warned.

Study groups in NCT05743686
Study groupRoleWhat they receive
ApplicationExperimentalNot described
Receives: Device: Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of calls

    The number of calls to the pharmacists and the navigator nurses will be recorded.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2023
  2. Study start16 Jan 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05743686
Sponsor's protocol ID
2021-5644
Status last verified
Mar 2026
First submitted
15 Feb 2023
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Application in people with Breast Neoplasms and Chemotherapeutic Toxicity, run by Julie Lemieux at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of calls (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in