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Oncologic DiseasesMCMVNCT07402057

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

A study testing My Care My Voice Intervention in people with Oncologic Diseases and Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Oncologic Diseases, Cancer
What is being tested?
My Care My Voice Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
271 participants
Where
4 sitesBelgium
Study dates
17 Mar 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium4 sites, 4 recruiting
  • AZorg

    Aalst, East-Flanders, 9300

    Ciska Langmans, MD, +32 5 372 86 01, ciska.langmans@azorg.be

    Sofie Moens, +32 5 372 86 01, sofie.moens@azorg.be

    Recruiting
  • AZ Maria Middelares

    Ghent, East-Flanders, 9000

    Emilie Janssens, MD, +32 9 246 27 50, Emilie.Janssens@mijnziekenhuis.be

    Aurélie Van Lancker, +32 9 246 27 50, Aurelie.VanLancker@mijnziekenhuis.be

    Recruiting
  • Ghent University Hospital

    Ghent, East-Flanders, 9000

    Aglaja De Pauw, MD, +32 9 332 26 91, aglaja.depauw@uzgent.be

    Anne-Lore Scherrens, PhD, +32 9 332 36 25, AnneLore.Scherrens@UGent.be

    Recruiting
  • AZ Groeninge

    Kortrijk, West-Flanders, 8500

    Tine Loyson, MD, +32 56 63 39 42, tine.loyson@azgroeninge.be

    Charlotte Vankeirsbilck, +32 56 63 39 42, Charlotte.Vankeirsbilck@azgroeninge.be

    Recruiting

Other trials in Belgium

About this study

Official title: Implementation and Evaluation of "My Care My Voice": a Program Aimed at Facilitating Conversations About Topics Such as Palliative 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.

Read the detailed description

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:

  1. 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.
  1. 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.)
  1. 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

Being tested
My Care My Voice Intervention
Keywords
Palliative Care, Early palliative care, Cancer, Oncology, Patient-physician communication, Patient empowerment, Health promotion, Behavioral change, Quality of life
Medical subject headings
Neoplasms, Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Care My Voice InterventionBehavioural

    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.

Study groups in NCT07402057
Study groupRoleWhat they receive
My Care My Voice InterventionExperimentalParticipants 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.
Receives: Behavioral: My Care My Voice Intervention
Standard careNo interventionParticipants receive standard oncological care without the My Care My Voice intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start17 Mar 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
271 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07402057
Sponsor's protocol ID
ONZ-2025-0500
Other IDs
1295225N
Acronym
MCMV
Status last verified
Apr 2026
First submitted
21 Jan 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32613675
  • 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.

    PubMed 36131548

Questions about this trial

What is this clinical trial studying?

A study testing My Care My Voice Intervention in people with Oncologic Diseases and Cancer, run by University Hospital, Ghent at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From pre-measurement to post-measurement (max. 6 months later)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07402057, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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