(Cost-)effectiveness and implementation of a decision aid for patients with prostate cancer

(Cost-)effectiveness and implementation of a decision aid for patients with localized prostate cancer and their partners: study protocol of a stepped wedge cluster randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21482

Enrollment

465

Registered

2015-05-28

Start date

2014-02-01

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

Localized prostate cancer

Interventions

Control group: patients with prostate cancer (and their partners), who have a choice for a curative treatment option and who receive care as usual by health care providers in participating centers.

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed adult patients with localized prostate cancer (and their partners) who have made a decision for a curable treatment option for prostate cancer, but have not undergone this treatment yet

Exclusion criteria

Exclusion criteria: Patients (and their partners) younger than 18 years, patients (and their partners) who are not able to understand the Dutch language in speech and in writing, patients who do not have a choice for multiple treatment options for localized prostate cancer. TNM classification: T4, N1, M1

Design outcomes

Primary

Measure	Time frame
- PATIENTS Decisional conflict - PARTNERS Effect of prostate cancer in the relationship: study-specific questionnaire based on the study of Zeliadt Communication between patient and partner and interaction with HCPs: Study-specific questionnaire based on the study of Zeliadt Social contacts and support: Active Engagement Scale (AES)	—

Secondary

Measure	Time frame
- PATIENTS Quality of life (EORTC QLQ-C30 and PR25) Treatment preferences (study-specific questionnaire) Experienced participation and approach to decision making (study-specific questionnaire based on the Perceived Participation of Deber) Expectations of the treatment (SETS pre-treatment) Outcome of the treatment (SETS post-treatment) Subjective and objective knowledge about prostate cancer (based on DQI knowledge, Karen Sepucha (Massachusettes General Hospital) and PCA 0915 of Carrie Levin) Communication between patient and partner (study-specific questionnaire based on the study of Zeliadt) The need for supportive care (SCNS SF-34 and prostate module) Decision regret (DRS) COST-EVALUATION Quality of life for the benefit of cost analysis (EQ5D) Registration of aftercare (TiC-P) Productivity Costs (PRODISQ) SATISFACTION WITH INTERVENTION Use of the PDA (study-specific questionnaire) Appreciation for the PDA (study-specific questionnaire) Satisfaction with the use of the PDA (SCIP-B) Preparation for decision making (Prep-DM) Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré) - PARTNERS Quality of life of partners (SF-12) Treatment preferences (study-specific questionnaire) Experienced participation and approach to decision making (study-specific questionnaire based on the Perceived Participation of Deber) Role as caregiver (CSI) SATISFACTION WITH INTERVENTION Use of the PDA (study-specific questionnaire) Appreciation for the PDA (study-specific questionnaire) Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré) MODERATING FACTORS PATIENTS AND PARTNERS Socio-demographic questionnaire with clinical variables Monitoring and blunting coping styles IMPLEMENTATION IMPLEMENTATION Implementation rate number of participating hospitals and proportion participating HCPs per hospital as a proportion of total number of all HCPs treating prostate cancer patients	—

Measure

Time frame

- PATIENTS Quality of life (EORTC QLQ-C30 and PR25) Treatment preferences (study-specific questionnaire) Experienced participation and approach to decision making (study-specific questionnaire based on the Perceived Participation of Deber) Expectations of the treatment (SETS pre-treatment) Outcome of the treatment (SETS post-treatment) Subjective and objective knowledge about prostate cancer (based on DQI knowledge, Karen Sepucha (Massachusettes General Hospital) and PCA 0915 of Carrie Levin) Communication between patient and partner (study-specific questionnaire based on the study of Zeliadt) The need for supportive care (SCNS SF-34 and prostate module) Decision regret (DRS) COST-EVALUATION Quality of life for the benefit of cost analysis (EQ5D) Registration of aftercare (TiC-P) Productivity Costs (PRODISQ) SATISFACTION WITH INTERVENTION Use of the PDA (study-specific questionnaire) Appreciation for the PDA (study-specific questionnaire) Satisfaction with the use of the PDA (SCIP-B) Preparation for decision making (Prep-DM) Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré) - PARTNERS Quality of life of partners (SF-12) Treatment preferences (study-specific questionnaire) Experienced participation and approach to decision making (study-specific questionnaire based on the Perceived Participation of Deber) Role as caregiver (CSI) SATISFACTION WITH INTERVENTION Use of the PDA (study-specific questionnaire) Appreciation for the PDA (study-specific questionnaire) Promoting and impeding factors using the PDA (study-specific questionnaire based on the study of Légaré) MODERATING FACTORS PATIENTS AND PARTNERS Socio-demographic questionnaire with clinical variables Monitoring and blunting coping styles IMPLEMENTATION IMPLEMENTATION Implementation rate number of participating hospitals and proportion participating HCPs per hospital as a proportion of total number of all HCPs treating prostate cancer patients

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Contacts

Public ContactHoda Al-Itejawi

Afdeling Urologie, kamer 4F 028

h.al-itejawi@vumc.nl+31 20 444 3116

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)