Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer

Digestive System Neoplasms Clinical Trial

— EmoVie_K2  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556344
• Other study ID #: 2019_69
• Secondary ID: 2020-A00674-35
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Alexis Cortot, MD,PhD
• Phone: +33 3 20 44 49 98
• Email: alexis.cortot[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms
• Thoracic Neoplasms

Intervention

Behavioral:
• Emotional skills
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.
• Short free talk and relaxation
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.

Locations

Country	Name	City	State
France	Hôpital Calmette,CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	SCALab UMR CNRS 9193

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Difficulties in Emotional Regulation	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)
Secondary	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).
Secondary	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)
Secondary	Patient participation in workshops	The percentage of patients who have attended the 3 group sessions	Between 2 weeks and 2 months
Secondary	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
Secondary	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)