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


- candidate number22246
- NTR NumberNTR5177
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-mei-2015
- Secondary IDs2013-444 METc VU medisch centrum
- Public Title(Cost-)effectiveness and implementation of a decision aid for patients with prostate cancer
- Scientific Title(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
- ACRONYMPatient Decision Aid Prostate cancer
- hypothesisPatient decision aids (PDA) for prostate cancer have been developed to help patients make a deliberative choice for a treatment option for their disease. Despite proven benefits of PDAs, structural implementation falls short of expectations. To overcome the hurdles with implementation, we developed a PDA for patients with localized prostate cancer using an iterative participatory approach. In the present study, we aim to investigate (cost-) effectiveness and implementation of this PDA for patients with localized prostate cancer and their partners. By using a stepped wedge cluster randomized controlled trial, we aim to achieve sustainable implementation of the PDA when proven (cost-)effective.
The PDA will be sequentially implemented in 18 hospitals in the region of Amsterdam, The Netherlands, over a period of 22 months (March 2014 to December 2015). In each hospital, there will be period of 4 to 19 months of including newly diagnosed patients who receive usual care, followed by a period of 3 to 18 months in which the PDA is provided to newly diagnosed patients and their partners. Baseline assessment takes place between the choice for a treatment option and the start of the treatment, with follow up assessments at 3, 6 and 12 months follow-up. The primary outcome measure for patients is reduction of decisional conflict (DCS). Furthermore, for patients a cost-evaluation will be performed (EQ-5D, TIC-P, PRODISQ). The primary outcome measures for partners are the effect of prostate cancer on the relationship and communication between patient, partner and health care professionals (study-specific questionnaire based on the study of Zeliadt), and social contacts and support (AES). Patients and partners receiving the PDA will also be asked about their satisfaction with the PDA (study-specific questionnaire based on the study of Légaré).
Outcome measures on implementation include the implementation rate and a questionnaire for health care professionals on determinants of an innovation (the PDA). We hypothesize that patients using the PDA leads to less decisional conflict in choosing a treatment decision. Sub hypotheses include that patients who use the PDA will choose more active surveillance as treatment option, will perceive more participation, have more realistic expectations of the treatment options, have more knowledge about prostate cancer and will communicate more with their partner about prostate cancer. Furthermore, patients who use the PDA will be expected not to differ from patients who will receive usual care in loss of productivity and need for supportive care.
- Healt Condition(s) or Problem(s) studiedLocalized prostate cancer
- Inclusion criteriaNewly 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 criteriaPatients (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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate16-jun-2017
- Target number of participants465
- InterventionsControl 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.
Intervention group: patients with prostate cancer (and their partners), who have a choice for a curative treatment option and who additionally to care as usual by health care providers in participating centers, will receive the PDA.
- Primary outcome- 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 outcome- 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, and approximate proportion of patients provided with the PDAs as a proportion of total number of eligible patients per participating hospital (retrieved from the Netherlands Cancer Registry). Measurement instrument for determinants of innovation (MIDI) among HCPs
- TimepointsBaseline assessment T0 patients and partners
Between choice and treatment

Assessment T1 patients and partners
3 months after treatment

Assessment T2 patients and partners
6 months after treatment

Assessment T3 patients and partners
12 months after treatment

* After treatment follow up is defined as the last day after irradiation in case of brachytherapy or external beam radiation therapy or the day after the removal of the catheter in case of surgery, or the day after choosing for active surveillance.

MIDI for HCPs: 3 months after implementation in participating hospital
- Trial web sitewww.prostaatkankerkeuzehulp.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Hoda Al-Itejawi
- CONTACT for SCIENTIFIC QUERIESDr. André Vis
- Sponsor/Initiator CZ, health insurance company, Astellas Pharma B.V.
- Funding
(Source(s) of Monetary or Material Support)
CZ zorgverzekeringen, Astellas Pharma B.V
- Publications
- Brief summaryFor the treatment of localized prostate cancer, several treatment options are available, each with their own side effects. Ideally, a patient should be able to make a choice based on arguments that weigh the most for him. This requires shared decision making, in which patients can make the decision for their treatment in collaboration with their urologist, supported by a patient decision aid (PDA). Despite proven benefits of PDA usage, structural implementation, falls short of expectations. This study was undertaken to implement a PDA and evaluate its effectiveness in a multi-center study. This randomized stepped wedge trial will take place in 18 centers, using a stepped wedge design. All centers start by including only control patients and their partners (i.e. no use of the PDA). Every 3 or 6 months a new cluster of two or four centers will start with the implementation of the PDA, and the inclusion of patients (and their partners) who used the PDA will start. Questionnaires will be send out to patients and their partners, prior to the treatment and after the decision for a treatment is made, 3 months, 6 and 12 months after the treatment. Partners will also be asked to fill in 4 questionnaires. Questionnaires include questions about satisfaction, decisional conflict and quality of life. The Netherlands
- Main changes (audit trail)
- RECORD28-mei-2015 - 24-mei-2017


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