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

NCT07402057 | Recruiting

• 2 other identifiers: ONZ-2025-05001295225N
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Oncologic Diseases; Cancer

Keywords

Palliative Care; Early palliative care; Cancer; Oncology; Patient-physician communication; Patient empowerment; Health promotion; Behavioral change; Quality of life

Outcome Measures

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.

  From pre-measurement to post-measurement (max. 6 months later)

Secondary Outcomes (5)

• 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

  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

  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

  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

  From pre-measurement to post-measurement (12 months later)

• Behavior in which physicians actually respond to a patient-initiated conversation about palliative care

  From pre-measurement to post-measurement (12 months later)

Other Outcomes (2)

• 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

  From pre-measurement to post-measurement (max. 6 months later)

• Socio-demographic and medical information

  From pre-measurement to post-measurement (max. 6 months later)

Study Arms (2)

My Care My Voice Intervention

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Participants receive standard oncological care without the My Care My Voice intervention.

Interventions

My Care My Voice Intervention BEHAVIORAL

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.

My Care My Voice Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \- Physician participating in My Care, My Voice
• 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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Algemeen Ziekenhuis Maria Middelares: collaborator
• ASZ Aalst: collaborator
• General Hospital Groeninge: collaborator
• University Ghent: collaborator

Study Sites (4)

AZorg

Aalst, East-Flanders, 9300, Belgium

RECRUITING

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

RECRUITING

AZ Groeninge

Kortrijk, West-Flanders, 8500, Belgium

RECRUITING

Related Publications (2)

• Scherrens AL, Cohen J, Mahieu A, Deliens L, Deforche B, Beernaert K. The perception of people with cancer of starting a conversation about palliative care: A qualitative interview study. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13282. doi: 10.1111/ecc.13282. Epub 2020 Jul 1.

  PMID: 32613675 BACKGROUND

• Scherrens AL, Beernaert K, Deliens L, Lapeire L, De Laat M, Biebuyck C, Geboes K, Van Praet C, Moors I, Deforche B, Cohen J. Identification of the most important factors related to people with cancer starting a palliative care conversation: A survey study. Psychooncology. 2022 Nov;31(11):1843-1851. doi: 10.1002/pon.6039. Epub 2022 Oct 9.

  PMID: 36131548 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Effect evaluation and process evaluation: A multicenter cluster non-equivalent controlled trial will be conducted to compare the My Care My Voice program (intervention group) with usual care (control group), including pre- and post-intervention assessments among both physicians and patients. The process evaluation will take place simultaneously with the post-intervention assessment.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 11, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

BE (4)