Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations

The current study aims to gain insight into the feasibility of the implementation plan of My Care My Voice (= preparation), its effectiveness in changing (the intention to) behavior (= effect evaluation), and the quality of the implementation process of the My Care My Voice intervention (= process evaluation). The study has three sub-objectives:

• PREPARATION: A preparatory study to assess the feasibility of the implementation plan for each of the participating hospitals. Feasibility is defined as the extent to which the study is acceptable and practically feasible within the clinical setting, without imposing an excessive burden on physicians or patients. This includes:

• The study description (aim, design, inclusion and exclusion criteria, data collection, and procedures): clarity
• The study flow (including timeline): advantages, disadvantages, and feasibility
• Recruitment by physicians: feasibility and support needs
• The informed consent process: comprehensibility and clarity
• Current workflow and consultation flow: how My Care My Voice can be integrated into existing practice → Specifically for the intervention hospitals, this includes examining how patients can be exposed to the materials (e.g., whether certain materials such as the video can be shown in the waiting room, and who - study nurse, oncology coach, etc. - can distribute materials such as the leaflet to each patient)

In this way, facilitators can be identified, as well as potential barriers (e.g., the use of the term "palliative care" during screening and recruitment is often a reason for non-participation), allowing them to be detected and addressed in a timely manner within each specific context. This constitutes an important preparatory step toward smooth recruitment, maximal exposure to the materials, and minimal burden, all of which are key indicators of a high-quality implementation process.

• EFFECT EVALUATION: To assess whether the My Care My Voice intervention is effective by comparing intervention hospitals with control hospitals:

• Expected effects among physicians: Changes in behavioral determinants (intention, knowledge, attitude, self-efficacy, perceived social norm) related to responding to palliative care conversations initiated by people with cancer, and to actually engaging in these conversations with people with cancer. (The hypothesis is that My Care My Voice will positively influence these behavioral determinants, increase physicians' intention to respond to patient-initiated palliative care conversations, and lead to more actual discussions about palliative care compared with usual care.)
• Expected effects among people with cancer: Changes in behavioral determinants (intention, knowledge, attitude, self-efficacy, perceived social norm) related to initiating a conversation about palliative care with their physician, and to actually initiating such a conversation. (The hypothesis is that My Care My Voice will positively influence these behavioral determinants, increase the intention to initiate palliative care conversations with their physician (intention = primary outcome), and result in more people with cancer actually initiating a palliative care conversation with their physician compared with usual care.)
• PROCESS EVALUATION: To evaluate why the My Care My Voice intervention was or was not effective. The aim is to evaluate both the intervention itself and the implementation process. The process evaluation is based on the UK MRC guidelines and includes:

• General impression: interesting, meaningful, clear
• Implementation: extent to which instructions and guidelines were followed and adapted; what went smoothly and what did not
• Contribution of the program: motivation, perceived impact on one's own views on palliative care (conversations) and clinical practice, perceived changes
• Context: influence of the following factors on the course of the intervention:

Physicians: time pressure, organizational and collegial support, patient behavior, relevance of other palliative care training Patients: role/function of the person who distributed the materials, frequency of consultations, positive or negative bad news conversations

Inclusion criteria

(physician):

• Oncologist (medical oncologist, radiation oncologist, etc.), radiologist, organ specialist, nuclear medicine physician, ASO
• The physician regularly interacts with people with advanced cancer
• The physician is employed in an oncology hospital department

Exclusion criteria

(physician):

• The physician works mostly (>50% of the time) in a hospital not involved in this study

Inclusion criteria

(healthcare provider - potential implementer):

• Healthcare provider (e.g., study coordinator, oncology coach) or another hospital staff member (e.g., administrative staff)
• The implementer regularly interacts with people with advanced cancer

Exclusion criteria

(healthcare provider - potential implementer):

• Physician participating in My Care, My Voice

Inclusion criteria

(patient):

• The participant is an adult (18 years or older)
• The participant has been diagnosed with advanced (i.e., non-curable) cancer (no curative treatment ongoing or planned). Participants receiving life-prolonging treatment are included.
• The participant is aware of their diagnosis and treatment options as determined by their physician
• The participant has known their initial diagnosis for more than one month
• The participant is able to participate in a Dutch-language study
• The participant is competent and able to voluntarily consent to participate in this study
• The participant is hospitalized or receiving outpatient care

Exclusion criteria

(patient):

• Estimated survival prognosis by the physician is longer than 5 years
• The participant is in a follow-up trajectory or in remission according to the physician
• The participant is already receiving specialized palliative care known to the treating physician