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PROstate cancer follow-up care in Secondary and Primary hEalth Care: PROSPEC study.

Recruiting
Conditions
Prostate cancer, survivorship, primary care, secondary care, follow-up, general practitioner, randomised controlled trialDutch: Prostaatcarcinoom, overlevingszorg, eerstelijnszorg, tweedelijnszorg, nazorg, huisarts, gerandomiseerd gecontroleerde trial.
Registration Number
NL-OMON24717
Lead Sponsor
Antoni van Leeuwenhoek-Netherlands Cancer Institute, Amsterdam, The Netherlands
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
390
Inclusion Criteria

1.Men diagnosed with invasive prostate cancer;

2.Stage cT1a–cT3; pNx–pN1; R0-1 having completed primary treatment (prostatectomy or radiotherapy);

Exclusion Criteria

1.Primary treatment (prostatectomy, radiotherapy) not completed at least 3 months previously;

2.Patients under active surveillance;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
To compare the effect of GP-based follow-up care of prostate cancer survivors with traditional, specialist-based follow-up care in terms of: <br /><br>(1) The time from a BCR to prostate cancer retreatment decision-making;<br /><br>(2) The management of treatment-related side effects (APECC survey);<br /><br>(3) Health-related quality of life and prostate cancer-related anxiety (EORTC QLQ-C30, QLQ-PR25 and MAX-PC questionnaire;<br /><br>(4) Continuity of care (NCQ survey);<br /><br>(5) Costs-effectiveness (EQ-5D-5L);<br /><br>(6) Experience with the follow-up and intervention study (interviews).
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