Digestive System NeoplasmsEmoVie_KNCT03306693
Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers
A study testing Emotional skills and Relaxation and talking group in people with Digestive System Neoplasms and Thoracic Neoplasms, run by University Hospital, Lille at 1 site in France.
Trial summary
The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a… 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 Relaxation and talking group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2017to 7 May 2019
- 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
- ≥18 ans,
- Oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the end of cancer treatments
- Patient of the CHRU (Regional Teaching Hospital) of Lille,
- Registered with a social security scheme
- Speak and understand French language
- Signature of the informed consent to participate in the study.
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 psychotherapy )
- 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 Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management
The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.
Read the detailed description
After the end of treatments, cancer patients face a difficult time because it is expected that they return to normal, but at the same time they still have to struggle with the aftermath of cancer and fear of recurrence. This is why there is room in this period for an intervention designed to help patients to cope with their emotions. . Patient emotional skills are patient abilities to identify, express and manage their emotions for the best possible psychological adjustment. In general population, emotional skills have been shown to be highly related to a better quality of life. In this randomized controlled study, bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end of treatments will undergo either the emotional skills intervention (intervention group) or the relaxation group (control group).
- Conditions
- Digestive System Neoplasms, Thoracic Neoplasms
- Being tested
- Emotional skills, Relaxation and talking group
- Keywords
- Emotional Intelligence, Quality of Life
- 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
Also called Emotional intelligence
2-hour 3 group sessions
Relaxation and talking groupBehavioural
2-hour 3 group sessions
| Study group | Role | What they receive |
|---|---|---|
| Emotional skills | Experimental | 3 group sessions where patients are going to learn how to identify, express and regulate their emotions Receives: Behavioral: Emotional skills |
| Relaxation and talking group | Sham comparator | 3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer Receives: Behavioral: Relaxation and talking group |
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 intervention
Variation of patient-reported Short Profile of Emotional Competence (S-PEC)questionnaire score from baseline to 15 days after the intervention (between 1 and 3 months)
Measured: Baseline and 15 days after the end of the intervention
Secondary outcomes (5)
Patient emotional skills long term
Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score
Measured: T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Measured: Baseline (T0), 15 days after the end of the intervention (T1), 2 months
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 and 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 posted11 Oct 2017
- Study start26 Oct 2017
- Primary completion7 May 2019
- Study completion7 May 2019
Why it stopped: insufficient inclusions
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- SIRIC ONCOLille, Santelys Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306693
- Sponsor's protocol ID
- 2016_29
- Other IDs
- 2017-A00224-49
- Acronym
- EmoVie_K
- Status last verified
- Sep 2020
- First submitted
- 4 Oct 2017
- Last updated
- 10 Sep 2020
- 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 10 Sep 2020. 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 Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management
- ClinicalTrials.gov ID
- NCT03306693
- Acronym / sponsor ID
- EmoVie_K / 2016_29
- Conditions
- Digestive System Neoplasms, Thoracic Neoplasms
- Keywords
- Emotional Intelligence, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient inclusions
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- SIRIC ONCOLille, Santelys Association
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 11 Oct 2017 (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 aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.
Detailed description
After the end of treatments, cancer patients face a difficult time because it is expected that they return to normal, but at the same time they still have to struggle with the aftermath of cancer and fear of recurrence. This is why there is room in this period for an intervention designed to help patients to cope with their emotions. . Patient emotional skills are patient abilities to identify, express and manage their emotions for the best possible psychological adjustment. In general population, emotional skills have been shown to be highly related to a better quality of life. In this randomized controlled study, bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end of treatments will undergo either the emotional skills intervention (intervention group) or the relaxation group (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 group sessions where patients are going to learn how to identify, express and regulate their emotions |
| Relaxation and talking group | Sham comparator | Behavioral: Relaxation and talking group3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about 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)
- ≥18 ans,
- Oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the end of cancer treatments
- Patient of the CHRU (Regional Teaching Hospital) of Lille,
- Registered with a social security scheme
- Speak and understand 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 psychotherapy )
- 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 skillsAlso: Emotional intelligence2-hour 3 group sessions | Behavioural | Emotional skills |
| Relaxation and talking group2-hour 3 group sessions | Behavioural | Relaxation and talking group |
Primary outcome
Change in patient emotional skills from baseline to 15 days after intervention
Time frame: Baseline and 15 days after the end of the intervention
Variation of patient-reported Short Profile of Emotional Competence (S-PEC)questionnaire score from baseline to 15 days after the intervention (between 1 and 3 months)
5 secondary outcomes
Patient emotional skills long term
Time frame: T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Time frame: Baseline (T0), 15 days after the end of the intervention (T1), 2 months
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 was stopped early (reason given: insufficient inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Relaxation and talking group 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: stopped early, as of the sponsor's last update on 10 Sep 2020. 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 was stopped early (reason given: insufficient inclusions). Results are not available in the source record.
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 intervention (time frame: Baseline and 15 days after the end of the intervention). 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 10 Sep 2020.