Short study overview

Background

Older patient with cancer have a higher risk of negative treatment outcomes and treatment decision-making can be complex. Elicitation of the goals and preferences of these patients can guide decision-making and is an important step in shared decision-making. However, healthcare professionals (HCP) and patients often find it difficult to engage in this conversation. There is a need for a method to structurally support this conversation. Health outcome prioritization, using the outcome prioritization tool (OPT), might be a good option to implement structural elicitation of goals and preferences and support shared decision-making. The aim of this study is to assess the feasibility of health outcome prioritization in different countries, cultures and settings, in an explorative multicentre study.

Main research question

Is health outcome prioritization a feasible method to elicit the goals and preferences of older patients with cancer in different countries and setting? Feasibility will be defined by the number of eligible patients who are able to prioritize their health outcomes.

Methods

Design: Prospective observational multicentre explorative study.

Method: Inclusion will take place during a 3 month period. Consecutive patients will be enrolled during a 3 month period. Intended start of the study is fall 2024. Health outcome prioritization, using the OPT, will be used to elicit patient preferences prior to decision-making. This can be performed by different HCP, depending on the local care trajectory. Eligible patients and HCP will be included after providing informed consent. Prior to decision-making, patient preferences will be elicited, using health outcome prioritization.

Population:

1) Patient with cancer of 70 years and older, who are possible candidates for surgery presenting at the surgical, oncology or geriatrics department. During the study period the OPT conversation will be implemented for all eligible patients. Eligible patients will be included in the study after providing written informed consent. Only for these patients data will be collected and analyzed.

2) Healthcare professionals (HCP). All involved HCP who perform the health outcome prioritization or the shared decision-making will be eligible to participate after providing written informed consent.

Outcome:

  • Primary outcome: feasibility of health outcome prioritization, using the OPT, defined as percentage of patients able to prioritize their health outcomes.
  • Secondary objectives: the association between frailty and prioritization of health outcomes, the possible cultural differences in prioritization of health outcomes, the most important health outcomes for older patients with cancer on the verge of making a treatment decision. Acceptability of health outcome prioritization from the perspective of HCP will be assessed by an online survey at the end of the inclusion period, using Likert Scale and open ended questions. At the end of this online survey the HCP will be invited to participate in a modified Delphi procedure to build consensus about the use of the OPT conversation in the care trajectory.

Expected results

Insight in the feasibility of health outcome prioritization, using the OPT, as a means to discuss patients preferences.

Practical issues

Start study

Fall 2024

Funding

This is a non-for-profit study promoted by SIOG surgical task force. No registration fee is requested to participate. No financial reimbursements will be made to participating centers/investigators.

Data

Anonymized data will be gathered using RedCap by the primary center (UMCG, Groningen, The Netherlands) and will only be accessible by the primary investigators. Each participating center is responsible for accurate data entry and has access to their data only. No data sharing will be performed with any third party. Personal data will be anonymized and confidential encrypted in a secure place within each local center.

Authorship

A maximum of 2 investigators from each individual surgical unit will be included as formal co-investigators in this research, and will obtain authorship. Each hospital may participate with different surgical units (GI, HBP, etc…) and should enrol a minimum number of 30 patients in order to claim 1 authorship, if the unit will enrol 30 more (60 total) this will trigger the second authorship. Other investigators will be mentioned in a group authorship.

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