Implementation and Evaluation of a Program Aimed at Facilitating Palliative Care Conversations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
Cancer is one of the leading causes of death worldwide. In the care of people with cancer, it is essential to pay sufficient attention to individual care needs and quality of life. One component of non-cancer-directed care, care aimed at addressing symptoms independent of the cancer or tumor, may be palliative care. Palliative care can be initiated at any point along the disease trajectory and can therefore be provided simultaneously with tumor-directed care. When initiated in a timely manner, palliative care can significantly improve the quality of life of both the person living with a life-threatening condition and their family. Pain management and attention to physical, psychosocial, and spiritual needs are central to this approach. Research shows that people with cancer develop palliative care needs well before the terminal phase. Communication about care needs, and palliative care in particular, is therefore essential for the timely initiation of palliative care.
However, to date, palliative care is often initiated too late or not at all, frequently resulting in suboptimal care during the final months of life. Communication about palliative care is postponed or avoided by both healthcare professionals and people with cancer. Efforts are being made at various levels to make palliative care more discussable and to initiate it in a timely manner. At present, however, these efforts primarily focus on the role of healthcare services and professionals. By focusing solely on healthcare providers, palliative care has not yet been fully integrated as a standard component of oncological practice. The literature indicates that, in addition to barriers, there are also opportunities at the level of the person with cancer when it comes to initiating a conversation about palliative care with their physician, provided that adequate support is available.
The health promotion approach, which focuses on the role of various personal and environmental factors in stimulating healthy behavior, is well suited to addressing this need for change in patient-initiated communication about palliative care. Health promotion makes use of theoretical behavioral models, for which evidence demonstrates that their application leads to more effective behavioral interventions and successful behavior change. These models have also been shown to be promising in promoting behaviors related to palliative care and in enhancing patient empowerment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
The physician works mostly (>50% of the time) in a hospital not involved in this study
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
The participant is an adult (18 years or older)
Trial design
Design model
Parallel
Treatments tested in this trial
My Care My Voice Intervention
BehavioralPhysicians will receive a poster, online training, and conversation card. People with cancer will receive an introductory video, poster, brochure with question and conversation cards, themed pen, and website.
Treatment groups
271 Participants
are divided into 2 treatment groupsGroup A: My Care My Voice InterventionExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change from pre-intervention measurement in the proportion of people with cancer who have a positive behavioral intention to initiate a conversation about palliative care with their physician at post-intervention measurement.
This primary outcome measure will be assessed using a study-specific self-report questionnaire developed by the research team, entitled Communication between people with cancer and their physician (Dutch language). The questionnaire will be completed by using the CAPI-method. Behavioral intention is a single item (I have the intention to start a conversation about palliative care with my physician), rated on a 5 point Likert Scale ranging from strongly disagree to strongly agree.
Time frame
From pre-measurement to post-measurement (max. 6 months later)Secondary outcomes
1
Behavioral, psychosocial, and perceived environmental factors related to initiating a conversation about palliative care with their physician or having a positive intention to do so
These outcome measures will be assessed using a study-specific self-report questionnaire developed by the research team, entitled Communication between people with cancer and their physician (Dutch language). Behavioral factors ared measured with 120 items. The questionnaire will be completed by using the CAPI-method. Most items are rated on a 5 point Likert Scale ranging from strongly disagree to strongly agree, except of knowledge of the behavior (yes-no) and social norm (5 point Likert Scale ranging from nobody to everybody).
Time frame
From pre-measurement to post-measurement (max. 6 months later)2
Behavioral, psychosocial, and perceived environmental factors related to responding to a conversation about palliative care initiated by the patient
These outcome measures will be assessed using a study-specific self-report questionnaire developed by the research team, entitled Communication about palliative care (Dutch language). The questionnaire will be completed online. Behavioral factors are measured with 42 items. Most items are rated on a 5 point Likert Scale ranging from strongly disagree to strongly agree, except of the behavior (5 point Likert Scale ranging from never to always), knowledge about palliative care (4 point Likert Scale ranging from not correct to very correct) and social norm (5 point Likert Scale ranging from nobody to everybody).
Time frame
From pre-measurement to post-measurement (12 months later)3
Behavior in which people with cancer actually initiate a conversation about palliative care with their physician
This will be assessed using a study-specific self-report questionnaire developed by the research team, entitled Communication between people with cancer and their physician (Dutch language). Behavior is a single-item measure using a 5 point Likert Scale ranging from strongly disagree to strongly agree, and will also be measured based on consultation notes obtained from the electronic patient record by the treating healthcare provider.
Time frame
From pre-measurement to post-measurement (max. 6 months later)4
Physicians who have a positive intention to respond to a patient-initiated conversation about palliative care
hese outcome measures will be assessed using a study-specific self-report questionnaire developed by the research team, entitled Communication about palliative care (Dutch language). The questionnaire will be completed online. Physician behavioral intention is measured with a single item, using a 5 point Likert Scale ranging from strongly disagree to strongly agree.
Time frame
From pre-measurement to post-measurement (12 months later)Other outcomes
1
Quality of life in people with incurable cancer, focusing on key symptoms and functioning using 15 questions covering physical/emotional function, pain, fatigue, appetite loss, insomnia, dyspnea, nausea/vomiting, constipation, and overall QoL
Change from pre-intervention measurement in the quality of life at the post-intervention measurement. QoL will be assessed using the EORTC QLQ-C15-PAL: 15 items using a 4 point Likert Scale ranging from not at all to very much.
Time frame
From pre-measurement to post-measurement (max. 6 months later)2
Socio-demographic and medical information
These outcome measures will be assessed using both study-specific self-report questionnaire (patient + physician) developed by the research team (Dutch language). Patient: 9 items Physician: 13 items
Time frame
From pre-measurement to post-measurement (max. 6 months later)Sponsors and contacts
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University Hospital, Ghent
Lead sponsor
Algemeen Ziekenhuis Maria Middelares
Collaborator
ASZ Aalst
Collaborator
General Hospital Groeninge
Collaborator
University Ghent
Collaborator
Source ClinicalTrials.gov