Prostate cancer, survivorship, primary care, secondary care, follow-up, general practitioner, randomised controlled trial Dutch: Prostaatcarcinoom, overlevingszorg, eerstelijnszorg, tweedelijnszorg, nazorg, huisarts, gerandomiseerd gecontroleerde trial.
Conditions
Interventions
The intervention is based on a primary care model where prostate cancer survivors will be referred to their GP for follow-up and aftercare after the first follow-up visit at the hospital. All patients
Sponsors
Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men diagnosed with invasive prostate cancer; 2. Stage cT1a–cT3; pNx–pN1; R0-1 having completed primary treatment (prostatectomy or radiotherapy); 3. Radiotherapy with or without androgen deprivation therapy (ADT) for localized prostate cancer 4. No evidence of recurrence (PSA<0.1 ng/ml after prostatectomy or PSA< nadir+2.0 ng/mL after radiotherapy).
Exclusion criteria
Exclusion criteria: 1. Primary treatment (prostatectomy, radiotherapy) not completed at least 3 months previously; 2. Patients under active surveillance; 3. Under investigation for possible recurrence (patients become eligible if recurrence is ruled out); 4. Does not have a community-based GP to provide care; 5. Unable to comply with study protocol including completion of questionnaires; 6. Actively followed by a cancer specialist for another primary cancer; 7. (Previously) enrolled in a study requiring ongoing follow-up by a cancer specialist; 8. Serious (treatment related) toxicity that requires treatment; 9. Patients that cannot sign informed consent or are unable to understand Dutch.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare GP-based follow-up care of prostate cancer survivors with traditional, specialist-based follow-up care in terms of adherence to the prostate surveillance guideline represented by the rate of PSA measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of GP-based follow-up care of prostate cancer survivors with traditional, specialist-based follow-up care in terms of: (1) The time from a BCR to prostate cancer retreatment decision-making; (2) The management of treatment-related side effects (APECC survey); (3) Health-related quality of life and prostate cancer-related anxiety (EORTC QLQ-C30, QLQ-PR25 and MAX-PC questionnaire; (4) Continuity of care (NCQ survey); (5) Costs-effectiveness (EQ-5D-5L); (6) Experience with the follow-up and intervention study (interviews). | — |
Contacts
Public ContactBarbara M.H.E. Wollersheim
Outcome results
None listed