Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743686
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-28
First Post:
2023-02-15
Brief Title:
App for Adverse Events to Oral Chemotherapy - Pilot Study
Sponsor:
Julie Lemieux
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Pilot Study of the Use of an App for the Follow-up of Oral Chemotherapy in Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CDK46 inhibitors have been added to the therapeutic arsenal A meta-analysis of clinical trials of first-line metastatic CDK46 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 eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None