Digestive System NeoplasmsEmoVie_K2NCT04556344
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer
A study testing Emotional skills and Short free talk and relaxation in people with Digestive System Neoplasms and Thoracic Neoplasms, run by University Hospital, Lille at 1 site in France.
Trial summary
Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Neoplasms, Thoracic Neoplasms
- What is being tested?
- Emotional skills and Short free talk and relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2020to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
- Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
- Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
- Affiliation to a social security scheme,
- Mastery of the French language,
- Signing of informed consent to participate in this research.
Who cannot join
- Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
- Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
- Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapeutic follow-up))
- Patients under judicial protection (guardianship or curators).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)
Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.
- Conditions
- Digestive System Neoplasms, Thoracic Neoplasms
- Being tested
- Emotional skills, Short free talk and relaxation
- Keywords
- Emotional Intelligence, Quality of Life, cancer survivors, psychology, supportive care
- Medical subject headings
- Digestive System Neoplasms, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional skillsBehavioural
3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
Short free talk and relaxationBehavioural
3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
| Study group | Role | What they receive |
|---|---|---|
| Emotional skills | Experimental | 3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions Receives: Behavioral: Emotional skills |
| Short free talk and relaxation | Sham comparator | 3 individual sessions in which patients are going to follow relaxation instructions after a non-directive talk about their current or past experience of cancer. Receives: Behavioral: Short free talk and relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient emotional skills from baseline to 15 days after the end of intervention
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)
Measured: Between Baseline (T0) and 15 days after the intervention (T1)
Secondary outcomes (7)
Patient emotional skills at follow up
Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).
Measured: Between T0 (start of the intervention) and T2 (2 months after T1)
Difficulties in Emotional Regulation
Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.
Measured: Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)
Quality of life by FACT-G
Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Measured: At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).
Change in quality of life using FACT-G
Variation in assessed quality of life (FACT-G) between T0 and T1 and between T1 and T2 based on variation in emotional competence (13-item S-PEC)
Measured: Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)
Patient participation in workshops
The percentage of patients who have attended the 3 group sessions
Measured: Between 2 weeks and 2 months
Patient adherence to exercises to do at home between sessions
The percentage of patients who have performed the suggested exercises at home between sessions
Measured: Between 2 weeks and 2 months
Patient satisfaction
Patient-reported satisfaction regarding the intervention using ad hoc questionnaire
Measured: T1 (15 days after the end of the intervention) and T2 (2 months after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start26 Oct 2020
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- SCALab UMR CNRS 9193
- Responsible party
- Sponsor
- Investigators
- Alexis Cortot, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556344
- Sponsor's protocol ID
- 2019_69
- Other IDs
- 2020-A00674-35
- Acronym
- EmoVie_K2
- Status last verified
- May 2022
- First submitted
- 8 Sep 2020
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)
- ClinicalTrials.gov ID
- NCT04556344
- Acronym / sponsor ID
- EmoVie_K2 / 2019_69
- Conditions
- Digestive System Neoplasms, Thoracic Neoplasms
- Keywords
- Emotional Intelligence, Quality of Life, cancer survivors, psychology, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- SCALab UMR CNRS 9193
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 21 Sep 2020 (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.
Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emotional skills | Experimental | Behavioral: Emotional skills3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions |
| Short free talk and relaxation | Sham comparator | Behavioral: Short free talk and relaxation3 individual sessions in which patients are going to follow relaxation instructions after a non-directive talk about their current or past experience of cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
- Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
- Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
- Affiliation to a social security scheme,
- Mastery of the French language,
Key exclusion criteria (4 listed)
- Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
- Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
- Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapeutic follow-up))
- Patients under judicial protection (guardianship or curators).
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 |
|---|---|---|
| Emotional skills3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone. | Behavioural | Emotional skills |
| Short free talk and relaxation3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone. | Behavioural | Short free talk and relaxation |
Primary outcome
Change in patient emotional skills from baseline to 15 days after the end of intervention
Time frame: Between Baseline (T0) and 15 days after the intervention (T1)
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)
7 secondary outcomes
Patient emotional skills at follow up
Time frame: Between T0 (start of the intervention) and T2 (2 months after T1)
Difficulties in Emotional Regulation
Time frame: Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)
Quality of life by FACT-G
Time frame: At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).
Change in quality of life using FACT-G
Time frame: Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)
Patient participation in workshops
Time frame: Between 2 weeks and 2 months
Patient adherence to exercises to do at home between sessions
Time frame: Between 2 weeks and 2 months
Patient satisfaction
Time frame: T1 (15 days after the end of the intervention) and T2 (2 months after T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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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. This study is not recruiting at the moment.
Alexis Cortot, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional skills and Short free talk and relaxation in people with Digestive System Neoplasms and Thoracic Neoplasms, run by University Hospital, Lille at 1 site in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient emotional skills from baseline to 15 days after the end of intervention (time frame: Between Baseline (T0) and 15 days after the intervention (T1)). 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 5 Dec 2025.