Shared decision making in Perihilar Cholangiocarcinoma and Hepatocellular Adenoma: The SAPACHA study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22521

Enrollment

Registered

2020-02-20

Start date

2020-02-20

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

Perhilar cholangiocarcinoma en hepatocellular adenoma

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria - Age > 18 years - Newly diagnosed patients with PHC or HCA - Capable of providing written and oral informed consent

Exclusion criteria

Exclusion criteria: - Insufficient understanding of the Dutch language or cognitively unable to complete Dutch questionnaires.

Design outcomes

Primary

Measure	Time frame
The change in the level of patient involvement during PHC and HCA consultations in which a treatment decision is to be made, with the DSTs, scored objectively by independent observers with the use of the OPTION-5 instrument.	—

Secondary

Measure	Time frame
1. Increase of subjective use of SDM according to patients. This will be evaluated using the SDM Q-9 questionnaire, as measured at baseline and after implementation 2. Increase of subjective use of SDM according to physicians. This will be evaluated using the SDM Q-doc questionnaire, as measured at baseline and after implementation 3. The change in level of quality of life. This will be evaluated using the EORTC QLQ-C30[17] and EORTC QLQ-BIL21[18] questionnaires. 4. The change in level of adherence with the chosen treatment option. The chosen treatment is obtained from the recording and compared with the eventually received treatment obtained from the participating surgeon / gastroenterologist. 5. Decisional conflict, the decisional conflict in patients is scored using the Decisional Conflict Scale (DCS)[19]. 6. The level of disease-specific knowledge in patients is scored after consultation with the physician. This is measured by the use of a small questionnaire about the disease and associated treatments. 7. The, change in, duration of the consultation with the physician (i.e. do the implementations change the time of the visit?). The duration of the consultation prior to and after the implementation of the DST is measured and compared using the audiotape of the consultation. 8. The change in experienced anxiety. The change is experienced anxiety is measured using the Visual Analogue Scale for Anxiety (VAS-A scale)[20].	—

Measure

Time frame

1. Increase of subjective use of SDM according to patients. This will be evaluated using the SDM Q-9 questionnaire, as measured at baseline and after implementation 2. Increase of subjective use of SDM according to physicians. This will be evaluated using the SDM Q-doc questionnaire, as measured at baseline and after implementation 3. The change in level of quality of life. This will be evaluated using the EORTC QLQ-C30[17] and EORTC QLQ-BIL21[18] questionnaires. 4. The change in level of adherence with the chosen treatment option. The chosen treatment is obtained from the recording and compared with the eventually received treatment obtained from the participating surgeon / gastroenterologist. 5. Decisional conflict, the decisional conflict in patients is scored using the Decisional Conflict Scale (DCS)[19]. 6. The level of disease-specific knowledge in patients is scored after consultation with the physician. This is measured by the use of a small questionnaire about the disease and associated treatments. 7. The, change in, duration of the consultation with the physician (i.e. do the implementations change the time of the visit?). The duration of the consultation prior to and after the implementation of the DST is measured and compared using the audiotape of the consultation. 8. The change in experienced anxiety. The change is experienced anxiety is measured using the Visual Analogue Scale for Anxiety (VAS-A scale)[20].

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Contacts

Public ContactAlicia Furumaya

Amsterdam UMC, University of Amsterdam

a.furumaya@amsterdamumc.nl+31683258089

Outcome results