Table 2 Outcome measures
Description of outcome | Assessment | Description of measure |
|---|---|---|
Sociodemographic and clinical data | Sociodemographic data, disease and treatment characteristics will be abstracted from medical records or reported by the patient. | Patient reported: place of birth, marital status, educational level, employment, lifestyle factors (i.e. smoking, alcohol consumption, length and weight), and the self-administered comorbidity questionnaire [43]. |
Medical records: birth-month and year, hospital where primary treatment took place, referred specialist, date of diagnosis, date and type of treatment, tumor characteristics (clinical and pathological stage). | ||
Primary outcome | ||
 Adherence to the prostate cancer surveillance guideline (Table 1) | PSA measurements | Number of PSA measurements will be abstracted from medical records. |
Secondary outcomes | ||
 The time from a BCR to prostate cancer retreatment decision-making | PSA value and referrals | The time from any detectable PSA level (> 0.2 ng/mL after surgery, > 2.0 ng/mL over nadir after radiotherapy) to the decision of prostate cancer retreatment in the hospital. |
 The management of treatment-related side effects | Assessment of Patients’ Experience of Cancer Care (APECC) survey [44] | 37 items, organized into 10 scales in the following six areas: access to care; interaction with physicians; interaction with other members of the health care team; discussion of health promotion; perceptions of coordination of care; and the management of treatment-related side effects. |
 Health-related quality of life | EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) [45] | 30 items, organized into 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (pain, fatigue, and emesis), 6 items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and an overall QL scale. |
 Prostate cancer-related quality of life | EORTC Prostate cancer specific module (PR25) [46] | 25 items, organized into 5 scales (urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning) and one item (incontinence aid). |
 Prostate cancer-related anxiety | 18 items, organized into one scale consisting of 3 subscales (general prostate cancer anxiety, anxiety related to PSA levels in particular, and fear of recurrence). | |
 Continuity of care | Nijmegen Continuity Questionnaire (NCQ) [49] | 28 items, organized into one scale consisting of 3 subscales (personal continuity, care provider knows me and shows commitment, and team/cross-boundary continuity). |
 Cost-effectiveness | EuroQol 5-Dimension (EQ-5D-5L) [50] | 5 items (dimensions) multi-attribute utility questionnaire that measures mobility, self-care, usual activities, pain/discomfort and anxiety/depression in 5 levels. |
Health care costs | Medical activities abstracted from the management systems of the hospitals and GP practices | |
Indirect costs | Patient reported productivity losses [51], medical consumption [52] and travel costs | |