Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
urinary incontinence |
The Expanded Prostate Cancer Index Short Form (EPIC-26) is a questionnaire that assesses symptoms and functions of people with prostate cancer in 5 domains. A total of 100 points can be achieved for each domain, with a higher score indicating better function. The urinary incontinence domain consists of four items. To calculate the primary endpoint, the difference between the scores on the urinary incontinence scale of the EPIC-26 is taken at 52 and 6 weeks. Changes regarding urinary incontinence (Minimally Important Difference (MID) >= 9) at 52 weeks postoperatively compared with 6 weeks postoperatively are considered. |
52 weeks |
|
Secondary |
EPIC-26: changes in sexual function |
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in in sexual function according to EPIC-26 (MID >= 10). |
52 weeks |
|
Secondary |
EPIC-26: changes in irritative/obstructive symptoms |
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in irritative/obstructive an gastrointestinal symptoms according to EPIC-26 (MID >= 7). |
52 weeks |
|
Secondary |
EPIC-26: changes in gastrointestinal symptoms |
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes an gastrointestinal symptoms according to EPIC-26 (MID >= 5). |
36 months |
|
Secondary |
EPIC-26: changes in vitality/hormonal function |
Similar to the primary endpoint, changes at 52 weeks postoperatively compared with 6 weeks postoperatively are considered for the changes in vitality/ hormonal function according to EPIC-26 (MID >= 4). |
52 weeks |
|
Secondary |
EQ-5D-5L: changes in health-related quality of life (HRQoL) |
The European Quality of Life Five-Dimensions Questionnaire (EQ-5D-5L) measures health-related quality of life on five scales: 1. mobility, 2. ability to care for oneself, 3. activities of daily living, 4. pain/physical discomfort, and 5. anxiety/dejection, each of which is represented by a question that provides five response options for grading symptoms. In addition, a question on self-assessment of health status is asked on a visual analog scale from 0 to 100, where 100 is the best imaginable health. |
52 weeks |
|
Secondary |
PHQ-4: changes in depressivity |
The Patient Health Questionnaire-4 (PHQ-4) measures depressiveness and generalized anxiety on two subscales with two items each. For each question, scores from 0 to 3 can be achieved, so that a cumulative score of 12 points can be reached, whereby a higher score indicates a more pronounced symptomatology. The cut-off value for depressivity is defined for the subscales of the PHQ-4 is definied by >= 3 points, the respective attainment of which (independent of the preoperative value) triggers an alarm at each survey time point. |
52 weeks |
|
Secondary |
PHQ-4: changes in generalised anxiety |
The Patient Health Questionnaire-4 (PHQ-4) measures depressiveness and generalized anxiety on two subscales with two items each. For each question, scores from 0 to 3 can be achieved, so that a cumulative score of 12 points can be reached, whereby a higher score indicates a more pronounced symptomatology. The cut-off value for depressivity is defined for the subscales of the PHQ-4 is definied by >= 3 points, the respective attainment of which (independent of the preoperative value) triggers an alarm at each survey time point. |
52 weeks |
|
Secondary |
PEI: changes in patient enablement |
The Patient Enablement Instrument (PEI) measures patient empowerment through six questions; a validated German translation with a modified question sequence and Likert scale is used. Overall, the sum score ranges from 6 to 30 points, with a higher score corresponding to greater patient empowerment. |
52 weeks |
|
Secondary |
qualitative process evaluation - module 1: feasibility |
semi-structured interviews with patients, urologists, psychooncologists, study nurses (N=10-15); data from Module 1 will be evaluated qualitatively using content analysis; criteria are based on the feasibility criteria for evaluating the acceptance and feasibility of the intervention and the study procedures |
52 weeks |
|
Secondary |
qualitative process evaluation - module 2: impact |
sequential semi-structured interviews with patients and relatives from the intervention and control groups in the main study (N=30-40); data from module 2 will be evaluated by contrastive thematic coding; in addition to possible differences between the intervention and control groups, intraindividual changes are also evaluated by contrastive coding of the data material at several time points |
52 weeks |
|
Secondary |
qualitative process evaluation - module 3: implementation |
Semi-structured interviews with urologists, psychooncologists, study nurses in the main study (N=10-15); focus group discussion with study participants; analysis of implementation factors is guided by the Consolidated Framework for Advancing Implementation Science (CFIR); data from module 3 on implementation are evaluated qualitatively by content analysis |
52 weeks |
|