Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management

Conditions
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Digestive System Neoplasms, Thoracic Neoplasms

Intervention / Treatment
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* Behavioral: Emotional skills
* Behavioral: Relaxation and talking group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotional skills<br>3 group sessions where patients are going to learn how to identify, express and regulate their emotions | Behavioral: Emotional skills<br>* 2-hour 3 group sessions<br>* Other names: Emotional intelligence;|
| Sham Comparator: Relaxation and talking group<br>3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer | Behavioral: Relaxation and talking group<br>* 2-hour 3 group sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and 15 days after the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient emotional skills long term | Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score | 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) | 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 | 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 and ad hoc questionnaire | T1 (15 days after the end of the intervention) and T2 (2 months after T1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotional Intelligence, Quality of Life