Skip to main content
. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NTR5177.

Trial name or 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
Methods RCT
Participants 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

  • 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.
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.
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.
Outcomes Primary outcomes

  • Decisional conflict (patients)

  • Effect of prostate cancer in the relationship (partners)

  • Communication between patient and partner and interaction with HCPs

  • Social contacts and support: Active Engagement Scale (AES)


Secondary outcomes
Patients

  • Quality of life (EORTC QLQ‐C30 and PR25)

  • Treatment preferences

  • Experienced participation and approach to decision making

  • Expectations of the treatment (SETS pre‐treatment)

  • Outcome of the treatment (SETS post‐treatment)

  • Subjective and objective knowledge about prostate cancer

  • Communication between patient and partner

  • 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

  • Appreciation for the PDA

  • Satisfaction with the use of the PDA (SCIP‐B)

  • Preparation for decision making (Prep‐DM)

  • Promoting and impeding factors using the PDA


Partners

  • Quality of life of partners (SF‐12)

  • Treatment preferences

  • Experienced participation and approach to decision making

  • 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


Moderating factors patients and partners

  • Socio‐demographic questionnaire with clinical variables Monitoring and blunting coping styles


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
Starting date February 2014
Contact information Dr. André Vis, +31 20 444 0261, a.vis@vumc.nl
Notes