Clinical trial NCT03306693: Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Digestive System Neoplasms
Thoracic Neoplasms
Keywords: Emotional Intelligence
Quality of Life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: SIRIC ONCOLille
name: Santelys Association
First posted: 2017-10-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Change in patient emotional skills from baseline to 15 days after intervention
timeFrame: Baseline and 15 days after the end of the intervention
Secondary outcomes:
measure: Patient emotional skills long term
timeFrame: T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
measure: Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
timeFrame: Baseline (T0), 15 days after the end of the intervention (T1), 2 months
measure: Patient participation in workshops
timeFrame: Between 2 weeks and 2 months
measure: Patient adherence to exercises to do at home between sessions
timeFrame: Between 2 weeks and 2 months
measure: Patient satisfaction
timeFrame: T1 (15 days after the end of the intervention) and T2 (2 months after T1)
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Calmette,CHU
Study officials:
References: