Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome (PRO-P)

Heinrich-Heine University, Duesseldorf

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: current clinical practice; Other: complex intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05644821

2022-2148

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 3 patient groups

Intervention group

Experimental group

Description:

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the intervention group, when the respective questionnaire thresholds 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 actions, if necessary.

Treatment:

Other: complex intervention

Control group

No Intervention group

Description:

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the control group, ePROMs will be collected 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group will therefore receive treatment according to the current clinical routine.

Comparison group

Other group

Description:

In patients who are fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours), ePROMs are collected at 24 and 52 weeks, but no alarms or further actions are derived from them. Thus, treatment is provided according to routine clinical practice. Patients are not randomized.

Treatment:

Other: current clinical practice