Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial
<b>Background/Objectives:</b> During radiotherapy for prostate cancer, the risk of radiation cystitis is increased if the volume of the bladder is small. According to previous studies, it is important that bladder volumes are ≥200 mL. Drinking protocols may be helpful in this context. Ad...
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MDPI AG
2025-02-01
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| Series: | Clinics and Practice |
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| Online Access: | https://www.mdpi.com/2039-7283/15/3/40 |
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| author | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Christian Ziemann Stefan Janssen Julia Koeck Justus Domschikowski Charlotte Kristiansen Christine Vestergård Madsen Marciana N. Duma Tobias Bartscht Jon Cacicedo Florian Cremers |
| author_facet | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Christian Ziemann Stefan Janssen Julia Koeck Justus Domschikowski Charlotte Kristiansen Christine Vestergård Madsen Marciana N. Duma Tobias Bartscht Jon Cacicedo Florian Cremers |
| author_sort | Dirk Rades |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> During radiotherapy for prostate cancer, the risk of radiation cystitis is increased if the volume of the bladder is small. According to previous studies, it is important that bladder volumes are ≥200 mL. Drinking protocols may be helpful in this context. Adherence to such protocols can be challenging, and may be improved by an app reminding patients before each session of radiotherapy to drink a certain amount of water. Our prospective phase 2 trial (REFILL-PAC-HYPO, NCT06784115) evaluates the impact of a reminder app on bladder filling in prostate cancer patients treated with hypo-fractionated radiotherapy. <b>Methods:</b> Twenty-seven patients need to be recruited for the REFILL-PAC-HYPO trial. Radiotherapy, preferably with volumetric-modulated arc therapy, uses hypo-fractionation with 20 × 3.0 Gy over four weeks. An app reminds patients to drink water (300 mL) 45 min before each session of hypo-fractionated irradiation. On the last day of their treatment, patients are asked about their satisfaction with the app. In the case of a dissatisfaction rate of >20%, the app requires modifications. If this rate is >40%, the app is considered not useful. Additionally, patients are asked about the impact of their participation in the trial and using the app on their general attitude towards health technology. Furthermore, the phase 2 cohort is compared to a historical control group treated with hypo-fractionated radiotherapy during recent years but not supported by an app. The REFILL-PAC-HYPO trial will contribute to identifying the potential value of a reminder app for bladder filling during hypo-fractionated radiotherapy for prostate cancer. |
| format | Article |
| id | doaj-art-ede091d48d1b4ab5a2a8bbf55ed549c0 |
| institution | Kabale University |
| issn | 2039-7283 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Clinics and Practice |
| spelling | doaj-art-ede091d48d1b4ab5a2a8bbf55ed549c02025-08-20T03:43:11ZengMDPI AGClinics and Practice2039-72832025-02-011534010.3390/clinpract15030040Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO TrialDirk Rades0Jan-Dirk Küter1Michael von Staden2Ahmed Al-Salool3Christian Ziemann4Stefan Janssen5Julia Koeck6Justus Domschikowski7Charlotte Kristiansen8Christine Vestergård Madsen9Marciana N. Duma10Tobias Bartscht11Jon Cacicedo12Florian Cremers13Department of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, GermanyDepartment of Radiotherapy, Malteser Hospital St. Franziskus, 24939 Flensburg, GermanyDepartment of Radiotherapy, Malteser Hospital St. Franziskus, 24939 Flensburg, GermanyDepartment of Oncology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, DenmarkDepartment of Oncology, Vejle Hospital, University Hospital of Southern Denmark, 7100 Vejle, DenmarkDepartment of Radiotherapy, Helios Hospital Schwerin, 19055 Schwerin, GermanyDepartment of Hematology, Oncology and Stem Cell Transplantation, Helios Hospital Schwerin, 19055 Schwerin, GermanyRadiation Oncology Department, University of the Basque Country, 48903 Barakaldo, Vizcaya (Basque Country), SpainDepartment of Radiation Oncology, University Medical Center Schleswig-Holstein, Lübeck Campus, 23538 Lübeck, Germany<b>Background/Objectives:</b> During radiotherapy for prostate cancer, the risk of radiation cystitis is increased if the volume of the bladder is small. According to previous studies, it is important that bladder volumes are ≥200 mL. Drinking protocols may be helpful in this context. Adherence to such protocols can be challenging, and may be improved by an app reminding patients before each session of radiotherapy to drink a certain amount of water. Our prospective phase 2 trial (REFILL-PAC-HYPO, NCT06784115) evaluates the impact of a reminder app on bladder filling in prostate cancer patients treated with hypo-fractionated radiotherapy. <b>Methods:</b> Twenty-seven patients need to be recruited for the REFILL-PAC-HYPO trial. Radiotherapy, preferably with volumetric-modulated arc therapy, uses hypo-fractionation with 20 × 3.0 Gy over four weeks. An app reminds patients to drink water (300 mL) 45 min before each session of hypo-fractionated irradiation. On the last day of their treatment, patients are asked about their satisfaction with the app. In the case of a dissatisfaction rate of >20%, the app requires modifications. If this rate is >40%, the app is considered not useful. Additionally, patients are asked about the impact of their participation in the trial and using the app on their general attitude towards health technology. Furthermore, the phase 2 cohort is compared to a historical control group treated with hypo-fractionated radiotherapy during recent years but not supported by an app. The REFILL-PAC-HYPO trial will contribute to identifying the potential value of a reminder app for bladder filling during hypo-fractionated radiotherapy for prostate cancer.https://www.mdpi.com/2039-7283/15/3/40prostate cancerhypo-fractionated radiation therapybladder filling statusradiation cystitisreminder app |
| spellingShingle | Dirk Rades Jan-Dirk Küter Michael von Staden Ahmed Al-Salool Christian Ziemann Stefan Janssen Julia Koeck Justus Domschikowski Charlotte Kristiansen Christine Vestergård Madsen Marciana N. Duma Tobias Bartscht Jon Cacicedo Florian Cremers Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial Clinics and Practice prostate cancer hypo-fractionated radiation therapy bladder filling status radiation cystitis reminder app |
| title | Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial |
| title_full | Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial |
| title_fullStr | Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial |
| title_full_unstemmed | Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial |
| title_short | Evaluation of Reminder App for Optimization of Bladder Filling Status During Hypo-Fractionated Irradiation for Prostate Cancer: Protocol of REFILL-PAC-HYPO Trial |
| title_sort | evaluation of reminder app for optimization of bladder filling status during hypo fractionated irradiation for prostate cancer protocol of refill pac hypo trial |
| topic | prostate cancer hypo-fractionated radiation therapy bladder filling status radiation cystitis reminder app |
| url | https://www.mdpi.com/2039-7283/15/3/40 |
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