No registrations found.
ID
Source
Brief title
Health condition
Early phase clinical trial
Palliative care
Value clarification tool
Patient-physician communication
Sponsors and support
Antoni van Leeuwenhoek, Amsterdam
UMC Utrecht
Intervention
Outcome measures
Primary outcome
For WP1, the main study endpoint will be the delivery of a ready to implement online value clarification tool. For WP2 this will be decisional conflict measured by the Dutch version of the Decisional Conflict Scale (DCS).
Secondary outcome
Secondary study parameters for WP1 include the life values of patients, experiences with patient-physician communication, and
the fit and value of the online value clarification tool.
Secondary outcomes for WP2 include the communication process, decision making process, discussion of patients’ values and
preferences, consultation duration, and actual usage of the tool.
Background summary
Patients for whom standard anti-cancer treatment is no longer available may be offered participation in early phase clinical trials. In the preceding consent procedure, both technical information and values and preferences of patients need to be discussed. Given the complexity of these trials, focus on the information may prevail without a clear patient-physician discussion on patient values, actual prognosis and palliative care options. Decisional conflict has been reported in patients after deciding on participation. This project aims to develop and evaluate an online tool to clarify patients’ values around end-of-life decisions and support them in the decision to participate (or not) in a clinical trial.
Study objective
We hypothesize that clarifying the values of patients with incurable cancer without regular treatment options will empower patients and will create more effective patient-physician communication which helps to better attune communication to the individual patient needs. We hypothesize that an online value clarification tool aids in better value clarification and thus helps patients in this decision making process, which will be evaluated by assessing patients’ decisional conflict.
Study design
Start inclusion: from October 1, 2018
Intervention
n.a.
C.C.D. Rijt, van der
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391906
c.vanderrijt@erasmusmc.nl
C.C.D. Rijt, van der
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391906
c.vanderrijt@erasmusmc.nl
Inclusion criteria
For the patients:
- Diagnosed with advanced cancer for whom standard systemic therapy is not or no longer available;
- medically fit enough to be offered participation in early phase clinical trials;
- aged 18 years or older;v
- sufficient command of the Dutch language;
- written informed consent.
For the (healthy) oncologists:
- member of a trial oncologists (study) team.
Exclusion criteria
For the patients:
- Cognitive impairment (e.g. dementia) according to the medical record;
- no access to the Internet.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7335 |
| NTR-old | NTR7551 |
| CCMO | NL65568.078.18 |