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PRECYCLE

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PRECYCLE : multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant. / Degenhardt, Tom; Fasching, Peter A; Lüftner, Diana; Müller, Volkmar; Thomssen, Christoph; Schem, Christian; Witzel, Isabell; Decker, Thomas; Tesch, Hans; Kümmel, Sherko; Uleer, Christoph; Wuerstlein, Rachel; Hoffmann, Oliver; Warm, Mathias; Marschner, Norbert; Schinköthe, Timo; Kates, Ronald E; Schumacher, Johannes; Otremba, Burkhard; Zaiss, Matthias; Harbeck, Nadia; Schmidt, Marcus; PreCycle Investigators.

In: TRIALS, Vol. 24, No. 1, 17.05.2023, p. 338.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Degenhardt, T, Fasching, PA, Lüftner, D, Müller, V, Thomssen, C, Schem, C, Witzel, I, Decker, T, Tesch, H, Kümmel, S, Uleer, C, Wuerstlein, R, Hoffmann, O, Warm, M, Marschner, N, Schinköthe, T, Kates, RE, Schumacher, J, Otremba, B, Zaiss, M, Harbeck, N, Schmidt, M & PreCycle Investigators 2023, 'PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant', TRIALS, vol. 24, no. 1, pp. 338. https://doi.org/10.1186/s13063-023-07306-z

APA

Degenhardt, T., Fasching, P. A., Lüftner, D., Müller, V., Thomssen, C., Schem, C., Witzel, I., Decker, T., Tesch, H., Kümmel, S., Uleer, C., Wuerstlein, R., Hoffmann, O., Warm, M., Marschner, N., Schinköthe, T., Kates, R. E., Schumacher, J., Otremba, B., ... PreCycle Investigators (2023). PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant. TRIALS, 24(1), 338. https://doi.org/10.1186/s13063-023-07306-z

Vancouver

Degenhardt T, Fasching PA, Lüftner D, Müller V, Thomssen C, Schem C et al. PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant. TRIALS. 2023 May 17;24(1):338. https://doi.org/10.1186/s13063-023-07306-z

Bibtex

@article{29672ef563f04d8aaee45f77349d01b1,
title = "PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant",
abstract = "BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (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. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of 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 and compares 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 = "Humans, Female, Breast Neoplasms/pathology, Fulvestrant/therapeutic use, Aromatase Inhibitors/therapeutic use, Quality of Life, Protein Kinase Inhibitors/adverse effects, Patient Reported Outcome Measures, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Receptor, ErbB-2/metabolism",
author = "Tom Degenhardt and Fasching, {Peter A} and Diana L{\"u}ftner and Volkmar M{\"u}ller and Christoph Thomssen and Christian Schem and Isabell Witzel and Thomas Decker and Hans Tesch and Sherko K{\"u}mmel and Christoph Uleer and Rachel Wuerstlein and Oliver Hoffmann and Mathias Warm and Norbert Marschner and Timo Schink{\"o}the and Kates, {Ronald E} and Johannes Schumacher and Burkhard Otremba and Matthias Zaiss and Nadia Harbeck and Marcus Schmidt and {PreCycle Investigators}",
note = "{\textcopyright} 2023. The Author(s).",
year = "2023",
month = may,
day = "17",
doi = "10.1186/s13063-023-07306-z",
language = "English",
volume = "24",
pages = "338",
journal = "TRIALS",
issn = "1745-6215",
publisher = "Current Controlled Trials Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - PRECYCLE

T2 - multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant

AU - Degenhardt, Tom

AU - Fasching, Peter A

AU - Lüftner, Diana

AU - Müller, Volkmar

AU - Thomssen, Christoph

AU - Schem, Christian

AU - Witzel, Isabell

AU - Decker, Thomas

AU - Tesch, Hans

AU - Kümmel, Sherko

AU - Uleer, Christoph

AU - Wuerstlein, Rachel

AU - Hoffmann, Oliver

AU - Warm, Mathias

AU - Marschner, Norbert

AU - Schinköthe, Timo

AU - Kates, Ronald E

AU - Schumacher, Johannes

AU - Otremba, Burkhard

AU - Zaiss, Matthias

AU - Harbeck, Nadia

AU - Schmidt, Marcus

AU - PreCycle Investigators

N1 - © 2023. The Author(s).

PY - 2023/5/17

Y1 - 2023/5/17

N2 - BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (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. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of 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 and compares 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.

AB - BACKGROUND: Efficacy and quality of life (QoL) are key criteria for therapy selection in metastatic breast cancer (MBC). In hormone receptor positive (HR +) human epidermal growth factor receptor 2 negative (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. However, the prerequisite is adherence to therapy over the entire course of treatment. However, particularly with new oral drugs, adherence presents a challenge to disease management. In this context, factors influencing adherence include maintaining patients' satisfaction and early detection/management of side effects. New strategies for continuous support of 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 and compares 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.

KW - Humans

KW - Female

KW - Breast Neoplasms/pathology

KW - Fulvestrant/therapeutic use

KW - Aromatase Inhibitors/therapeutic use

KW - Quality of Life

KW - Protein Kinase Inhibitors/adverse effects

KW - Patient Reported Outcome Measures

KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects

KW - Receptor, ErbB-2/metabolism

U2 - 10.1186/s13063-023-07306-z

DO - 10.1186/s13063-023-07306-z

M3 - SCORING: Journal article

C2 - 37198674

VL - 24

SP - 338

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

ER -