An interventional study of My Care My Voice Intervention in Oncologic Diseases and Cancer, sponsored by University Hospital, Ghent. Recruiting at 4 sites in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Supportive care
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.
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:
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:
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:
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
9,371 studies on the registry are indexed under Neoplasms; 2,492 are open to participants now.
This study's planned enrollment of 271 is above the median of 50 across 7,258 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Inclusion Criteria (physician):
Exclusion Criteria (physician):
Inclusion Criteria (healthcare provider - potential implementer):
Exclusion criteria (healthcare provider - potential implementer):
- Physician participating in My Care, My Voice
Inclusion Criteria (patient):
Exclusion Criteria (patient):
Participants receive the My Care My Voice intervention in addition to standard care, aimed at facilitating patient-initiated communication about palliative care between people with cancer and physicians.
Behavioral: My Care My Voice Intervention
Participants receive standard oncological care without the My Care My Voice intervention.
Physicians 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.
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)
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)
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)
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)
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)
Behavior in which physicians actually respond to a patient-initiated conversation about palliative care
The behavior 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. The physician behavior is measured with 7 items, using a 5 point Likert Scale ranging from never to always.
Time frame: From pre-measurement to post-measurement (12 months later)
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)
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)
Plan to share: Undecided
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University Hospital, Ghent