Clinical trial NCT04556344: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive System Neoplasms
Thoracic Neoplasms
Keywords: Emotional Intelligence
Quality of Life
cancer survivors
psychology
supportive care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: SCALab UMR CNRS 9193
First posted: 2020-09-21
Enrollment: 86
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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 psychotherapeutic follow-up))
* Patients under judicial protection (guardianship or curators).

Primary outcomes:
measure: Change in patient emotional skills from baseline to 15 days after the end of intervention
timeFrame: Between Baseline (T0) and 15 days after the intervention (T1)
Secondary outcomes:
measure: Patient emotional skills at follow up
timeFrame: Between T0 (start of the intervention) and T2 (2 months after T1)
measure: Difficulties in Emotional Regulation
timeFrame: Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)
measure: Quality of life by FACT-G
timeFrame: At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).
measure: Change in quality of life using FACT-G
timeFrame: Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)
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:
affiliation: University Hospital, Lille
name: Alexis Cortot, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: