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. 2024 Nov 12;25(1):754.
doi: 10.1186/s13063-024-08579-8.

PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial

Rouvier Al-Monajjed  1 , Peter Albers  1   2 , Johanna Droop  1 , Dominik Fugmann  3 , Joachim Noldus  4 , Rein-Jüri Palisaar  4 , Manuel Ritter  5 , Jörg Ellinger  5 , Philipp Krausewitz  5 , Michael Truß  6 , Boris Hadaschik  7 , Viktor Grünwald  7   8 , Andres-Jan Schrader  9 , Philipp Papavassilis  9 , Nicole Ernstmann  10 , Barbara Schellenberger  10 , Anna Moritz  10 , Christoph Kowalski  11 , Martin Hellmich  12 , Pierce Heiden  12 , Anna Hagemeier  12 , Dirk Horenkamp-Sonntag  13 , Markus Giessing  14 , Luis Pauler  15 , Sebastian Dieng  15 , Maria Peters  16 , Günter Feick  17 , André Karger  18 ; PRO-P study group
Collaborators, Affiliations

PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial

Rouvier Al-Monajjed et al. Trials. .

Abstract

Background: With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support.

Methods: The PRO-P ("Influence of ePROMS in surgical therapy of PC on the postoperative course") study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation.

Discussion: PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs.

Trial registration: ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

Keywords: Continence; EPIC-26; Health apps; PROM; Patient-reported outcomes; Prostate cancer; Quality of life; Radical prostatectomy.

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Conflict of interest statement

Declarations Ethics approval and consent to participate {24} The study is performed in accordance with the Helsinki Declaration and ICH guidelines on Good Clinical Practice (GCP). The Ethics Committee of the Medical Faculty of Heinrich Heine University, Düsseldorf, Germany, approved the study (Study No. 2022–2148). A data protection concept is provided. A data safety impact assessment has been performed. Written, informed consent to participate will be obtained from all participants. Participation is voluntary. Participants may withdraw from the study at any time without justification or negative impacts. Consent for publication {32} Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests {28} Christoph Kowalski is a staff member of the non-profit German Cancer Society, which is one of the institutions responsible for the certification system of cancer centers. Sebastian Dieng and Luis Pauler are employees of OnkoZert GmbH, the certification institute of the German Cancer Society, which is responsible for onsite audits in clinics, for the creation of the IT infrastructure, data collectio,n and the research platform. All other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure. Pre-op. = pre-operative; post-op. = post-operative; QoL = quality of life. *Comparison group: patients who are 6 weeks postoperatively urinary continent; **Survey of patients in the intervention group only
Fig. 2
Fig. 2
Schematic representation of the intervention
Fig. 3
Fig. 3
Study design and participant timeline
Fig. 4
Fig. 4
Consort data flow
See this image and copyright information in PMC

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