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Evaluation of information provision and treatment decision making for men with early-stage prostate cancer.

Prostate Cancer Patient-centered Care (PCPCC): impact of a treatment decision aid in a pragmatic, cluster randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22128
Enrollment
400
Registered
2014-05-01
Start date
2014-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Prostate cancer, prostaatkanker

Interventions

The control group will receive usual care
information provision and provided decisional support will be given according to the hospital standards. In addition to usual care, the intervention group will be granted access to an online decisio

Sponsors

Tilburg University, St. Elisabeth Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Men that are newly diagnosed with early stage prostate cancer; - Tumour stage T1 or T2; - Maximum PSA-score of 20; - Maximum Gleason-score of 7; - Patients who are eligible for at least two treatment options; - Patients (in the intervention arm) have to be able to make use of a computer with internet-access in order make use of the web-based decision aid. - Patients have to be able to read and understand Dutch language.

Exclusion criteria

Exclusion criteria: - Patients with advanced cancer; - If the urologist judges the patient is not in the right condition to participate; - In the case of a second opinion when the other involved hospital also uses a decision aid from this or an other study.

Design outcomes

Primary

MeasureTime frame
Decisional conflict (short term), decisional regret and treatment satisfaction (long term). All measured by questionnaires.

Secondary

MeasureTime frame
Decision making role, knowledge about prostate cancer, statisfaction with information, preparation for decision making, health-related quality of life, and personality (anxiety, depression, optimism) and skills measures (self-efficacy, health literacy, numeracy). All measured by questionnaires.

Contacts

Public ContactM. Cuypers

Tilburg University Social and Behavioral Sciences PO Box 90153

M.Cuypers@uvt.nl+31 13 466 28 55

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)