App for Adverse Events to Oral Chemotherapy - Pilot Study

Sponsor
Julie Lemieux (Other)
Overall Status
Recruiting
CT.gov ID
NCT05743686
Collaborator
(none)
30
1
1
11.5
2.6

Study Details

Study Description

Brief 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". 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Application
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pilot Study of the Use of an App for the Follow-up of Oral Chemotherapy in Breast Cancer Patients
Actual Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Sep 4, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Application

Device: Application
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.

Outcome Measures

Primary Outcome Measures

  1. Number of calls [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • =18 years of age

  • metastatic breast cancer

  • receiving oral chemotherapy (palbociclib, everolimus, or capecitabine)

  • possess an smartphone, a tablet, or a personal compiter

Exclusion Criteria:
  • cognitive impairments

Contacts and Locations

Locations

Site City State Country Postal Code
1 St-Sacrement Hospital Quebec City Quebec Canada G1S4L8

Sponsors and Collaborators

  • Julie Lemieux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julie Lemieux, Head of Clinical Research in Breast Cancer, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT05743686
Other Study ID Numbers:
  • 2021-5644
First Posted:
Feb 24, 2023
Last Update Posted:
Feb 28, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2023