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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00674-35 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| SCALab UMR CNRS 9193 | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotional skills | Experimental | 3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional skills | Behavioral | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Between Baseline (T0) and 15 days after the intervention (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Between T0 (start of the intervention) and T2 (2 months after T1) |
| Difficulties in Emotional Regulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexis Cortot, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Calmette,CHU | Lille | France |
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| Short free talk and relaxation | Behavioral | 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. |
|
Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2. |
| 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 | 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) | 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 | 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 | Between 2 weeks and 2 months |
| Patient satisfaction | Patient-reported satisfaction regarding the intervention using ad hoc questionnaire | T1 (15 days after the end of the intervention) and T2 (2 months after T1) |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D013899 | Thoracic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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