CHOICE: CHOosing treatment together In Cancer at the End of life<br>

Completed

• Conditions: itgezaaide, niet-operabele tumoren; Metastasized and inoperable tumours; incurable cancer; 10027656

• Registration Number: NL-OMON44961
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 192

Inclusion Criteria

Patients
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. diagnosed with metastasized or locally irresectable cancer
2. not eligible for treatment with curative intent
3. median life expectancy of <1 year without systemic treatment, and a median survival benefit of systemic treatment of <6 months. This includes, but is not limited to:
a. patients with metastases or locally irresectable tumors of the pancreas, esophageus, stomach, liver, gall bladder, and bladder, and patients with metastatic sarcoma or melanoma
b. patients with advanced cancer, irrespective of tumour type, who have experienced progression under first line palliative systemic treatment.
4. scheduled for a consultation with a participating medical oncologist in which decisions about the start, (dis)continuation or adjustment of palliative systemic treatment will be made. This includes consultations in which:
a. a decision to start, forego or postpone a (new line of) systemic treatment will be made
b. current systemic treatment is evaluated after a fixed number of cycles and a decision to (dis)continue and/or adjust systemic treatment will be made;Oncologists
Eligible are all medical oncologists (in training) treating the eligible patient population with an appointment of at least 1 year after the start of the trial.

Exclusion Criteria

Patients
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. insufficient mastery of Dutch, i.e., inability to understand the 'Gesprekswijzer' as well as the questionnaires as judged by either the physician or the researcher
2. cognitive disabilities or a psychiatric disorder that hinder understanding of the 'Gesprekswijzer' as well as the questionnaires as judged by either the physician or the researcher
3. not enough time (<2 days) to make sure the Gesprekswijzer is received before the consultation in which decisions are made
4. a primary brain tumor or brain metastasizes which significantly affect cognitive functioning;Oncologists
Excluded will be oncologists involved in the design of the content of the interventions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the level of SDM as observed in the consultation. To<br /><br>this end, we will audiotape the consultation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>o Observed SDM in a simulated patient encounter (effect training only)<br /><br>o Patients* perceived efficacy in communication before the consultation<br /><br>o Patient and oncologist satisfaction with communication and decision making<br /><br>o Congruence between patients* preferred and perceived role in decision making<br /><br>o Patients* attitudes towards striving for quantity (length) or quality of life<br /><br>o Patients* evaluation of the decision made<br /><br>o Patients* quality of life<br /><br>o Patients* trust in the oncologist<br /><br>o Patients* anxiety<br /><br>o Patients* fighting spirit<br /><br>o Consultation time<br /><br>o The treatment decision made<br /><br>o Patients* use of the *Gesprekswijzer*<br /><br>o Patients*evaluation of the *Gesprekswijzer*</p><br>