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Study protocol
Tom Degenhardt
LMU München: Ludwig-Maximilians-Universitat Munchen
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2886-7074
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Efficacy and quality of life (QoL) are key when selecting a therapy for metastatic breast cancer (MBC) patients. In hormone receptor positive (HR+) human epidermal growth factor receptor 2 minus (HER2-) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g. palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. Prerequiste for obtaining such benefit is adherence to therapy over the whole treatment duration. Adherence, maintaining patients’ satisfaction, early detection and management of side effects have thus become important challenges, in particular with these new oral drugs and new ways of continuous support for oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.
Methods: PreCycle is a multicenter, randomized, phase IV trial in HR+ HER2+ MBC. All patients (n=960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g. adherence), genetic background, and drug efficacy, the trial includes both patient reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).
Discussion: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform).
EudraCT Number: 2016-004191-22
Keywords
metastatic breast cancer, eHealth, patient reported outcome, Quality of life, CDK 4/6 inhibitor, endocrine therapy
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CURRENT STATUS: Under Revision
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Major revision
On 01 Oct, 2021
Review #3 received
Received 28 Sep, 2021
Reviewer #3 agreed
On 14 Sep, 2021
Review #2 received
Received 18 Aug, 2021
Reviewer #2 agreed
On 14 Jul, 2021
Review #1 received
Received 29 Jun, 2021
Reviews received
Received 18 Jun, 2021
Reviewer #1 agreed
On 18 Jun, 2021
Reviewers invited
Invitations sent on 18 Jun, 2021
Submission checks complete
On 03 Jun, 2021
Editor assigned
On 26 May, 2021
First submitted
On 12 Apr, 2021
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Tom Degenhardt
LMU München: Ludwig-Maximilians-Universitat Munchen
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2886-7074
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Revision
Version 1
Posted 07 Jun, 2021
No community comments so far
Editorial decision: Major revision
On 01 Oct, 2021
Review #3 received
Received 28 Sep, 2021
Reviewer #3 agreed
On 14 Sep, 2021
Review #2 received
Received 18 Aug, 2021
Reviewer #2 agreed
On 14 Jul, 2021
Review #1 received
Received 29 Jun, 2021
Reviews received
Received 18 Jun, 2021
Reviewer #1 agreed
On 18 Jun, 2021
Reviewers invited
Invitations sent on 18 Jun, 2021
Submission checks complete
On 03 Jun, 2021
Editor assigned
On 26 May, 2021
First submitted
On 12 Apr, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Efficacy and quality of life (QoL) are key when selecting a therapy for metastatic breast cancer (MBC) patients. In hormone receptor positive (HR+) human epidermal growth factor receptor 2 minus (HER2-) MBC, addition of targeted oral agents such as everolimus or a cycline-dependent kinase 4/6 (CDK 4/6) inhibitor (e.g. palbociclib, ribociclib, abemaciclib) to endocrine therapy substantially prolongs progression-free survival and in the case of a CDK 4/6i also overall survival. Prerequiste for obtaining such benefit is adherence to therapy over the whole treatment duration. Adherence, maintaining patients’ satisfaction, early detection and management of side effects have thus become important challenges, in particular with these new oral drugs and new ways of continuous support for oncological patients are needed. An eHealth-based platform can help to support therapy management and physician-patient interaction.
Methods: PreCycle is a multicenter, randomized, phase IV trial in HR+ HER2+ MBC. All patients (n=960) receive the CDK 4/6 inhibitor palbociclib either in first (62.5%) or later line (37.5%) together with endocrine therapy (AI, fulvestrant) according to national guidelines. PreCycle evaluates the time to deterioration (TTD) of QoL in patients supported by eHealth systems with substantially different functionality: CANKADO active vs. inform. CANKADO active is the fully functional CANKADO-based eHealth treatment support system. CANKADO inform is a CANKADO-based eHealth service with a personal login, documentation of daily drug intake, but no further functions. To evaluate QoL, the FACT-B questionnaire is completed at every visit. As little is known about relationships between behavior (e.g. adherence), genetic background, and drug efficacy, the trial includes both patient reported outcome and biomarker screening for discovery of forecast models for adherence, symptoms, QoL, progression free survival (PFS), and overall survival (OS).
Discussion: The primary objective of PreCycle is to test the hypothesis of superiority for time to deterioration (TTD) in terms of DQoL = “Deterioration of quality of life” (FACT-G scale) in patients supported by an eHealth therapy management system (CANKADO active) versus in patients merely receiving eHealth-based information (CANKADO inform).
EudraCT Number: 2016-004191-22
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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