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App for Adverse Events to Oral Chemotherapy - Pilot Study

Primary Purpose

Breast Neoplasms, Chemotherapeutic Toxicity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Application
Sponsored by
Julie Lemieux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St-Sacrement HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Application

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
February 24, 2023
Sponsor
Julie Lemieux
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1. Study Identification

Unique Protocol Identification Number
NCT05743686
Brief Title
App for Adverse Events to Oral Chemotherapy - Pilot Study
Official Title
Pilot Study of the Use of an App for the Follow-up of Oral Chemotherapy in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
September 4, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Lemieux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Chemotherapeutic Toxicity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of calls
Description
The number of calls to the pharmacists and the navigator nurses will be recorded.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St-Sacrement Hospital
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Hogue
Phone
4185254444
Ext
82424
Email
jean-charles.hogue@crchudequebec.ulaval.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

App for Adverse Events to Oral Chemotherapy - Pilot Study

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