Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Gastrointestinal Neoplasms

Thoracic Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Quality of Life

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

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.

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.

Emotional skills

Short free talk and relaxation

Alexis Cortot, MD,PhD

Eric Wasielewski

Sophie Lelorain, PhD

Christelle Duprez, PhD

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.

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

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)

Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)

Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).

Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.

Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire

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)

The percentage of patients who have attended the 3 group sessions

The percentage of patients who have performed the suggested exercises at home between sessions

Patient-reported satisfaction regarding the intervention using ad hoc questionnaire

SCALab UMR CNRS 9193

University Hospital, Lille

3 group sessions where patients are going to learn how to identify, express and regulate their emotions

3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer

Relaxation and talking group

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.

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).

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

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

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)

Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score

Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)

Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer	NCT04556344	Digestive Syste... Thoracic Neopla...	Emotional skill... Short free talk...	18 Years -	University Hospital, Lille
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer	NCT04556344	Digestive Syste... Thoracic Neopla...	Emotional skill... Short free talk...	18 Years -	University Hospital, Lille
Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers	NCT03306693	Digestive Syste... Thoracic Neopla...	Emotional skill... Relaxation and ...	18 Years -	University Hospital, Lille

Spots Global Cancer Trial Database for emotional skills