Clinical trial NCT05644821: Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome
Official title: Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Marienhospital Herne
name: University Hospital, Essen
name: University Hospital, Bonn
name: Klinikum Dortmund gGbmH
name: University Hospital Muenster
name: University Hospital of Cologne
name: University of Cologne
name: Techniker Krankenkasse
name: Deutsche Krebsgesellschaft e.V.
First posted: 2022-12-09
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intention-to-treat principle, comparison (regarding superiority) of primary endpoint using mixed linear model for repeated measures: dependent variable: primary endpoint, influencing factors: Indicator for intervention/control group, time, group\*time, center, tumor stage, and age group; downstream sequential-rejection testing of equality of expected values in the individual strata via appropriate contrasts; control of multiple error for at least one false rejection (final test principle); supplementary: mixed linear models with additional independent variables; sensitivity analyses on the influence of missing values (multiple imputation); subgroup analyses according to center, stage, and age group
Primary purpose: OTHER

Brief summary: The study investigates the influence of structured follow-up using ePROMS in the 1st year after prostatectomy on the postoperative course. It will be examined whether this intervention leads to early detection of postoperative symptoms and whether the subsequent initiation of further measures lead to an improvement of incontinence, symptom burden, quality of life and patient competence.

Detailed description: PRO-P is planned as a multicenter, prospective, and two-arm randomized control group study in which ePROMs will be performed in a standardized fashion once before and six times (intervention group) or three times (control group) after primary prostatectomy in patients with PCa. PROMs are collected either web-based or through a dedicated app and entered by the patient using either a mobile device or computer. Patients are invited to enter ePROMS into the app or web tool through email and app-driven push messages. Patients who are incontinent (at least one pad in 24 hours) at the 6-week postoperative survey are randomized into two groups: The intervention group and the control group. In the intervention group, when the respective questionnaire cut-off values are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center as well as subsequent measures, if necessary. This is done at 6 weeks postoperatively and at 12, 18, 24, 36 and 52 weeks postoperatively. In the control group, ePROMs are recorded 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group thus receives treatment in accordance with the current clinical routine. The mechanisms of action of the intervention will be investigated within the framework of a qualitative process evaluation. Characteristics on the patient level (e.g., treatment-related attitudes, comorbidity, social support), on the practitioner level (e.g., communication skills), on the organizational level, and the interactions between the levels (e.g., patient-doctor relationship) will be explored. The goal is to develop an intervention model, or to describe the effective elements of the intervention.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 y
* legal capacity
* sufficient knowledge of the German language
* prostate carcinoma, TNM T1-4 NX N0-1 M0-1c
* primary radical prostatectomy planned
* mobile input device or PC available
* ability to either receive emails or install a special app on cell phone and receive push messages, with guidance or assistance if necessary
* ability to complete electronic questionnaires, with guidance or assistance if necessary

Exclusion Criteria:

* palliative treatment situation (life expectancy \< 1 year)
* preoperative urinary incontinence (at least one pad per 24 hours)

Primary outcomes:
measure: urinary incontinence
timeFrame: 52 weeks
Secondary outcomes:
measure: EPIC-26: changes in sexual function
timeFrame: 52 weeks
measure: EPIC-26: changes in irritative/obstructive symptoms
timeFrame: 52 weeks
measure: EPIC-26: changes in gastrointestinal symptoms
timeFrame: 36 months
measure: EPIC-26: changes in vitality/hormonal function
timeFrame: 52 weeks
measure: EQ-5D-5L: changes in health-related quality of life (HRQoL)
timeFrame: 52 weeks
measure: PHQ-4: changes in depressivity
timeFrame: 52 weeks
measure: PHQ-4: changes in generalised anxiety
timeFrame: 52 weeks
measure: PEI: changes in patient enablement
timeFrame: 52 weeks
measure: qualitative process evaluation - module 1: feasibility
timeFrame: 52 weeks
measure: qualitative process evaluation - module 2: impact
timeFrame: 52 weeks
measure: qualitative process evaluation - module 3: implementation
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Clinic Bonn, Urology
state: North Rhine Westpahlia
city: Dortmund
country: Germany
facility: Klinikum Dortmund gGmbH, Urology
state: North Rhine Westphalia
city: Düsseldorf
country: Germany
facility: University Clinic Düsseldorf, Urology
state: North Rhine Westphalia
city: Herne
country: Germany
facility: University Clinik Bochum, Marienhospital Herne, Urology
state: North Rhine Westphalia
city: Münster
country: Germany
facility: University Clinic Münster, Urology
state: North Rhine Westphalia
Study officials:
affiliation: University Clinic Düsseldorf, Urology
name: Peter Albers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic Düsseldorf, psychosomatic medicine
name: André Karger, MD
role: STUDY_DIRECTOR
References: