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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48798
Enrollment
390
Registered
2018-04-04
Start date
2018-04-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostatic adenocarcinoma

Interventions

GP-based follow-up and aftercare for prostatecancer survivors

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Men diagnosed with invasive prostate cancer; - Stage cT1a - cT3; pNx - pN1; R0-1 having completed primary treatment (prostatectomy or radiotherapy); - Radiotherapy with or without androgen deprivation therapy (ADT) for localized prostate cancer - No evidence of recurrence (PSA

Exclusion criteria

Exclusion criteria: - Primary treatment (prostatectomy, radiotherapy) completed longer than 6 months previously; - Patients under active surveillance; - Under investigation for possible recurrence (patients become eligible if recurrence is ruled out); - Does not have a community-based GP to provide care; - Unable to comply with study protocol including completion of questionnaires; - Actively followed by a cancer specialist for another primary cancer; - (Previously) enrolled in a study requiring ongoing follow-up by a cancer specialist; - Serious (treatment related) toxicity that requires treatment; - Patients that cannot sign informed consent or are unable to understand Dutch.

Design outcomes

Primary

MeasureTime frame
Primary outcome is the effect of GP-based versus specialist-based follow-up care on adherence to the prostate cancer surveillance guideline.

Secondary

MeasureTime frame
Secondary outcomes include the time from a biochemical recurrence (BCR) to prostate cancer retreatment decision-making in an interdisciplinary setting, management of treatment-related side effects and comorbidities, health promotion recommendations, prostate-cancer related anxiety and quality of life, continuity of care, and cost-effectiveness.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)