Metastatic CancersNCT07236021
e-Motion : Promoting Emotion Regulation in Chronic Cancer
A study testing Guided Self-Help intervention and Group and Guided Self-Help intervention in people with Metastatic Cancers and Myeloma Multiple, run by Université Libre de Bruxelles at 2 sites in Belgium.
Trial summary
The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancers, Myeloma Multiple
- What is being tested?
- Guided Self-Help intervention and Group and Guided Self-Help intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 Nov 2025to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having received a diagnosis of chronic cancer (metastatic breast cancer, metastatic melanoma, metastatic colorectal, metastatic ovarian, metastatic uterine, metastatic endometrial, metastatic prostate, metastatic bladder, metastatic kidney or metastatic testicular cancer, symptomatic multiple myeloma, metastatic non-small cell lung, metastatic mesothelioma or metastatic thymoma) in the past 12 months,
- Having completed at least one active treatment session (e.g., chemotherapy, surgery, radiotherapy, immunotherapy, target therapy).
Who cannot join
- Having less than one year of life expectancy
- Having more than one treatment line (for triple negative breast cancer, melanoma, gynecological cancer, colorectal cancer, bladder cancer, kidney cancer, non-small cell lung, mesothelioma and thymoma) or two treatment lines (for other breast cancers and testicular cancer) or three treatment lines (for prostate cancer and multiple myeloma),
- Having a diagnosis of oligometastatic cancer,
- Age < 18 years,
- Non-fluency in French,
- Inability to follow the online intervention,
- Severe cognitive impairment, and severe and/or acute psychiatric disorder.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Not yet recruiting
Institut Jules Bordet, Hôpital universitaire de Bruxelles
Brussels, Anderlecht, 1070
Florence Lewis, PHD, +32 2 541 73 36, florence.lewis@hubruxelles.be
Isabelle Merckaert, Professor, +32 2 650 48 80, isabelle.merckaert@ulb.be
- Recruiting
H.U.B Institut Jules Bordet
Brussels, Brussels Capital, 1070
Florence Lewis, PhD, +325417336, florence.lewis@hubruxelles.be
About this study
Official title: Promoting Emotion Regulation in Patients Living With Chronic Cancer : A Pilot Feasibility, Acceptability and Tolerability Study (e-Motion Project)
The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. The primary aim of this pilot study is to assess the feasibility, acceptability and tolerability of the interventions. The secondary aim of the pilot study is to assess the interventions preliminary efficacy and differences on psychological symptoms.
Read the detailed description
The investigators aim to conduct a pilot study to assess feasibility, acceptability and tolerability of two interventions on 30 chronic cancer patients: a Guided Self-Help Intervention and a combined Group and Guided Self-Help Intervention. Both interventions will rely on emotion regulation component, with CBT, hypnosis, and positive psychology techniques.
The first 15 patients that will be recruited will be allocated to the Guided Self-Help Intervention (Arm 1). The recruitment of the 15 other patients will start after the last assessment of the last patient included in the first arm. These 15 other patients will be allocated by group of 5 to the combined Group and Guided Self-Help Intervention (Arm 2). Each participants will be assessed before intervention (T1), during intervention (Ecological weekly assessment, week 1 to week 12) and after the intervention (T2, 15 weeks after T1). T1 and T2 assessments will include self-reported questionnaires about psychological symptoms and a 7-day ecological momentary assessment (EMA) on emotions. In T2, a semi-structured interview will be performed for each participant to collect qualitative information on the tolerability and acceptability of the interventions. Participants will also complete a satisfaction questionnaire.
- Conditions
- Metastatic Cancers, Myeloma Multiple
- Being tested
- Guided Self-Help intervention, Group and Guided Self-Help intervention
- Keywords
- Advanced cancer, Cognitive Behavioral Therapy (CBT), Emotional regulation, Ecological Momentary Assessment (EMA), Hypnosis, Psychotherapy Group
- Medical subject headings
- Neoplasms, Multiple Myeloma, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Self-Help interventionBehavioural
This intervention will consist of 8 self-administered modules that patients will complete every week.
The sessions integrate an emotion regulation component with breathing exercises, relaxation exercises, hypnosis, etc. Once a week (maximum 15-minute), a trained psychologist will call the patient to help and/or encourage them. Each module will consist of podcasts, a reading assignment (with psycho-educational information) and writing assignments. The intervention will include home exercises and patients will be encouraged to practice exercises and skills learned between the sessions.
Group and Guided Self-Help interventionBehavioural
It will consist of the same content described above, but given in 8 group sessions (2-hour) held by videoconference (Zoom) that will take place every week. Patients will also have access to the podcasts, home exercises and reading assignment, but will benefit from increased motivation and support from both the therapist and their peers in the group. Each group will be composed of 5 patients.
| Study group | Role | What they receive |
|---|---|---|
| Guided Self-Help intervention arm | Active comparator | Guided self-help emotion regulation intervention for patient with chronic and incurable cancer. Receives: Behavioral: Guided Self-Help intervention |
| Group and Guided Self-Help intervention arm | Experimental | Group and guided self-help emotion regulation intervention for patient with chronic and incurable cancer. Receives: Behavioral: Group and Guided Self-Help intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
At least 25% of eligible patients agree to participate.
Measured: Baseline (T0)
Retention rate
At least 80% of patients complete the study to the end. The study completion rate is calculated based on the difference between the number of patients enrolled in T0 and those who completed the study in T2.
Measured: Baseline (T0), Weekly 15 (T2)
Adherence to intervention
At least 70% of patients complete all sessions regardless of the intervention arm. The weekly call includes a question asking participants whether they attended the week's session. Answer with Yes or No. If yes: go through all of the following questions. If no: investigate further to see if anything has been done."
Measured: Weeks 1 to 12 (intervention with weekly call)
Adherence to between-session practice
At least 70% of patients complete all assigned between-session exercises. The weekly call includes a question asking participants if they have done their exercises throughout the week. Answer with yes or no. The exercise completion rate between sessions is defined as the proportion of patients who reported having completed all weekly exercises among those who responded to the follow-up question.
Measured: Weeks 1 to 12 (intervention with weekly call)
Data completeness self-report questionnaire
At least 90% of patients complete all data of questionnaires at both time points (T1 and T2).
Measured: Baseline (T1) and Weekly 15 (T2)
Data completeness EMA
At least 70% of data are collected for the ecological momentary assessments.
Measured: Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)
Satisfaction of the intervention
At least 80% of patients rate the intervention as satisfactory. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates whether, overall, participants were satisfied with the intervention. Mean score is ≥ 4 in the satisfaction questionnaire. Satisfaction will also be assessed through a qualitative analysis (thematic analysis) of the transcript of the exit interview. The questionnaires were developed for this study.
Measured: Week 15 (T2)
Willingness to recommend
At least 80% of patients would recommend the intervention to other patients. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants would recommend this intervention to other patients in their situation. Mean score is ≥ 4 in the satisfaction questionnaire. The questionnaire was developed for this study.
Measured: Week 15 (T2)
Dropout rate due to intervention-related burden
No more than 10% of patients discontinue participation due to emotional distress or perceived burden linked to the intervention, as assessed by one question of the drop-out questionnaire which is: 'The reasons for this decision are related to: A. The intervention B. The questionnaires C. Both.' The percentage is calculated based on the number of patients who answered A or C.
Measured: Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)
Self-reported emotional impact
At least 80% of patients indicate that the intervention was emotionally manageable and not overly distressing. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants found this intervention emotionally comfortable or bearable. Mean score is ≥ 4 in the satisfaction questionnaire. Self-reported emotion impact will also be based on responses from the exit interviews (which is a semi-structured interview), assessed through a qualitative analysis (thematic analysis). The questionnaires were developed for this study.
Measured: Week 15 (T2)
Secondary outcomes (5)
The Generalized Anxiety Disorders 7 items (GAD-7)
The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The GAD-7, which is a validated 7-item, 4-point self-report questionnaire assessing anxiety symptoms. A higher score indicates higher levels of anxiety.
Measured: Baseline (T1), Week 15 (T2)
The Patient Health Questionnaire 9 items (PHQ-9)
The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The PHQ-9 which is a validated 10-item, 4-point self-report questionnaire assessing depressive symptoms. A higher score indicates higher levels of depression.
Measured: Baseline (T1), Week 15 (T2)
The Penn State Worry Questionnaire (PSWQ)
The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The PSWQ which is a validated 16-item, 5-point self-report questionnaire assessing worry. A higher score indicates higher levels of worry.
Measured: Baseline (T1), Week 15 (T2)
Fear of Cancer Recurrence Inventory (FCRI)
The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The FCRI (Fear of cancer progression modified Fear of Cancer Recurrence Inventory) : which is a validated 42-item, 5-point self-report questionnaire assessing seven dimensions of fear of cancer recurrence (0 = Never, 4 = All the time): triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. This scale has been validated in patients with metastatic cancer. However, to simplify the understanding of the items, the investigators have adapted it by substituting "fear of cancer recurrence" by "fear of cancer progression". Higher score indicates higher levels of fear of cancer progression.
Measured: Baseline (T1), Week 15 (T2)
Self-efficacy
The preliminary efficacy and interventions differences will be assessed using self-report questionnaires. The self-efficacy questionnaire was designed to assess patients' confidence in their ability to effectively manage and regulate their emotions. Self-efficacy was assessed using a questionnaire developed for this study, which is a 13 items on a 10-point Likert scale (0 = Not at all certain, 10 = Absolutely certain).
Measured: Baseline (T1), Week 15 (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start20 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- A pilot feasibility, acceptability and tolerability project. Two steps: The first included 15 patients will be assigned to a Guided Self-Help intervention. The second starts only after the first has ended. For this one, 15 other patients are recruited and assigned to a Group and Guided Self-Help intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Psycho-Oncologie (CPO), Jules Bordet Institute, Erasme University Hospital
- Responsible party
- Principal investigator, Prof. Isabelle Merckaert, Université Libre de Bruxelles
- Investigators
- Florence Lewis, PhD, Principal investigator, Université Libre de BruxellesIsabelle Merckaert, Professor, Study director, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236021
- Sponsor's protocol ID
- PO20250132
- Status last verified
- Nov 2025
- First submitted
- 5 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Emotion Regulation in Patients Living With Chronic Cancer : A Pilot Feasibility, Acceptability and Tolerability Study (e-Motion Project)
- ClinicalTrials.gov ID
- NCT07236021
- Acronym / sponsor ID
- PO20250132
- Conditions
- Metastatic Cancers, Myeloma Multiple
- Keywords
- Advanced cancer, Cognitive Behavioral Therapy (CBT), Emotional regulation, Ecological Momentary Assessment (EMA), Hypnosis, Psychotherapy Group
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- Centre de Psycho-Oncologie (CPO), Jules Bordet Institute, Erasme University Hospital
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aimed to pilot evaluate two interventions: a Guided Self-Help Intervention alone, and a combined Group and Guided Self-Help Intervention, designed to support individuals living with chronic cancer and recently diagnosed. The primary aim of this pilot study is to assess the feasibility, acceptability and tolerability of the interventions. The secondary aim of the pilot study is to assess the interventions preliminary efficacy and differences on psychological symptoms.
Detailed description
The investigators aim to conduct a pilot study to assess feasibility, acceptability and tolerability of two interventions on 30 chronic cancer patients: a Guided Self-Help Intervention and a combined Group and Guided Self-Help Intervention. Both interventions will rely on emotion regulation component, with CBT, hypnosis, and positive psychology techniques.
The first 15 patients that will be recruited will be allocated to the Guided Self-Help Intervention (Arm 1). The recruitment of the 15 other patients will start after the last assessment of the last patient included in the first arm. These 15 other patients will be allocated by group of 5 to the combined Group and Guided Self-Help Intervention (Arm 2). Each participants will be assessed before intervention (T1), during intervention (Ecological weekly assessment, week 1 to week 12) and after the intervention (T2, 15 weeks after T1). T1 and T2 assessments will include self-reported questionnaires about psychological symptoms and a 7-day ecological momentary assessment (EMA) on emotions. In T2, a semi-structured interview will be performed for each participant to collect qualitative information on the tolerability and acceptability of the interventions. Participants will also complete a satisfaction questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot feasibility, acceptability and tolerability project. Two steps: The first included 15 patients will be assigned to a Guided Self-Help intervention. The second starts only after the first has ended. For this one, 15 other patients are recruited and assigned to a Group and Guided Self-Help intervention.
| Arm | Type | Receives |
|---|---|---|
| Guided Self-Help intervention arm | Active comparator | Behavioral: Guided Self-Help interventionGuided self-help emotion regulation intervention for patient with chronic and incurable cancer. |
| Group and Guided Self-Help intervention arm | Experimental | Behavioral: Group and Guided Self-Help interventionGroup and guided self-help emotion regulation intervention for patient with chronic and incurable cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having received a diagnosis of chronic cancer (metastatic breast cancer, metastatic melanoma, metastatic colorectal, metastatic ovarian, metastatic uterine, metastatic endometrial, metastatic prostate, metastatic bladder, metastatic kidney or metastatic testicular cancer, symptomatic multiple myeloma, metastatic non-small cell lung, metastatic mesothelioma or metastatic thymoma) in the past 12 months,
- Having completed at least one active treatment session (e.g., chemotherapy, surgery, radiotherapy, immunotherapy, target therapy).
Key exclusion criteria (7 listed)
- Having less than one year of life expectancy
- Having more than one treatment line (for triple negative breast cancer, melanoma, gynecological cancer, colorectal cancer, bladder cancer, kidney cancer, non-small cell lung, mesothelioma and thymoma) or two treatment lines (for other breast cancers and testicular cancer) or three treatment lines (for prostate cancer and multiple myeloma),
- Having a diagnosis of oligometastatic cancer,
- Age < 18 years,
- Non-fluency in French,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Self-Help interventionThis intervention will consist of 8 self-administered modules that patients will complete every week. The sessions integrate an emotion regulation component with breathing exercises, relaxation exercises, hypnosis, etc. Once a week (maximum 15-minute), a trained psychologist will call the patient to help and/or encourage them. Each module will consist of podcasts, a reading assignment (with psycho-educational information) and writing assignments. The intervention will include home exercises and patients will be encouraged to practice exercises and skills learned between the sessions. | Behavioural | Guided Self-Help intervention arm |
| Group and Guided Self-Help interventionIt will consist of the same content described above, but given in 8 group sessions (2-hour) held by videoconference (Zoom) that will take place every week. Patients will also have access to the podcasts, home exercises and reading assignment, but will benefit from increased motivation and support from both the therapist and their peers in the group. Each group will be composed of 5 patients. | Behavioural | Group and Guided Self-Help intervention arm |
Primary outcome
Recruitment rate
Time frame: Baseline (T0)
At least 25% of eligible patients agree to participate.
Retention rate
Time frame: Baseline (T0), Weekly 15 (T2)
At least 80% of patients complete the study to the end. The study completion rate is calculated based on the difference between the number of patients enrolled in T0 and those who completed the study in T2.
Adherence to intervention
Time frame: Weeks 1 to 12 (intervention with weekly call)
At least 70% of patients complete all sessions regardless of the intervention arm. The weekly call includes a question asking participants whether they attended the week's session. Answer with Yes or No. If yes: go through all of the following questions. If no: investigate further to see if anything has been done."
Adherence to between-session practice
Time frame: Weeks 1 to 12 (intervention with weekly call)
At least 70% of patients complete all assigned between-session exercises. The weekly call includes a question asking participants if they have done their exercises throughout the week. Answer with yes or no. The exercise completion rate between sessions is defined as the proportion of patients who reported having completed all weekly exercises among those who responded to the follow-up question.
Data completeness self-report questionnaire
Time frame: Baseline (T1) and Weekly 15 (T2)
At least 90% of patients complete all data of questionnaires at both time points (T1 and T2).
Data completeness EMA
Time frame: Baseline (T1), Weeks 1 to 12 (Ecological weekly assessment), Weekly 15 (T2)
At least 70% of data are collected for the ecological momentary assessments.
Satisfaction of the intervention
Time frame: Week 15 (T2)
At least 80% of patients rate the intervention as satisfactory. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates whether, overall, participants were satisfied with the intervention. Mean score is ≥ 4 in the satisfaction questionnaire. Satisfaction will also be assessed through a qualitative analysis (thematic analysis) of the transcript of the exit interview. The questionnaires were developed for this study.
Willingness to recommend
Time frame: Week 15 (T2)
At least 80% of patients would recommend the intervention to other patients. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants would recommend this intervention to other patients in their situation. Mean score is ≥ 4 in the satisfaction questionnaire. The questionnaire was developed for this study.
Dropout rate due to intervention-related burden
Time frame: Baseline (T1), Weeks 1 to 12 (Intervention), Weekly 15 (T2)
No more than 10% of patients discontinue participation due to emotional distress or perceived burden linked to the intervention, as assessed by one question of the drop-out questionnaire which is: 'The reasons for this decision are related to: A. The intervention B. The questionnaires C. Both.' The percentage is calculated based on the number of patients who answered A or C.
Self-reported emotional impact
Time frame: Week 15 (T2)
At least 80% of patients indicate that the intervention was emotionally manageable and not overly distressing. This percentage is calculated based on the response to one of the questions in the satisfaction questionnaire, which is 1-item, 6-point self-report questionnaire (0 = Not at all, 6 = Absolutely). The question investigates the extent to which participants found this intervention emotionally comfortable or bearable. Mean score is ≥ 4 in the satisfaction questionnaire. Self-reported emotion impact will also be based on responses from the exit interviews (which is a semi-structured interview), assessed through a qualitative analysis (thematic analysis). The questionnaires were developed for this study.
5 secondary outcomes
The Generalized Anxiety Disorders 7 items (GAD-7)
Time frame: Baseline (T1), Week 15 (T2)
The Patient Health Questionnaire 9 items (PHQ-9)
Time frame: Baseline (T1), Week 15 (T2)
The Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline (T1), Week 15 (T2)
Fear of Cancer Recurrence Inventory (FCRI)
Time frame: Baseline (T1), Week 15 (T2)
Self-efficacy
Time frame: Baseline (T1), Week 15 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence Lewis, PhD principal investigator
Université Libre de Bruxelles
Isabelle Merckaert, Professor study director
Université Libre de Bruxelles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Self-Help intervention and Group and Guided Self-Help intervention in people with Metastatic Cancers and Myeloma Multiple, run by Université Libre de Bruxelles at 2 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 2 inclusion and 7 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Florence Lewis, PhD (+32 2 541 73 36, florence.lewis@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline (T0)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.