EmoVie_K2: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04556344

Collaborator

SCALab UMR CNRS 9193 (Other)

Enrollment

Location

Arms

35.2

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Neoplasms Thoracic Neoplasms	Behavioral: Emotional skills Behavioral: Short free talk and relaxation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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)

Actual Study Start Date :

Oct 26, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Emotional skills 3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions	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.
Sham Comparator: Short free talk and relaxation 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.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Emotional skills

3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions

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.

Sham Comparator: Short free talk and relaxation

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Change in patient emotional skills from baseline to 15 days after the end of intervention [Between Baseline (T0) and 15 days after the intervention (T1)]
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)

Secondary Outcome Measures

Patient emotional skills at follow up [Between T0 (start of the intervention) and T2 (2 months after T1)]
Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).
Difficulties in Emotional Regulation [Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)]
Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.
Quality of life by FACT-G [At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).]
Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Change in quality of life using FACT-G [Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)]
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)
Patient participation in workshops [Between 2 weeks and 2 months]
The percentage of patients who have attended the 3 group sessions
Patient adherence to exercises to do at home between sessions [Between 2 weeks and 2 months]
The percentage of patients who have performed the suggested exercises at home between sessions
Patient satisfaction [T1 (15 days after the end of the intervention) and T2 (2 months after T1)]
Patient-reported satisfaction regarding the intervention using ad hoc questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).