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

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

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.

Study Overview

• Status: Terminated
• Conditions: Digestive System Neoplasms; Thoracic Neoplasms
• Intervention / Treatment: Behavioral: Emotional skills; Behavioral: Relaxation and talking 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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Calmette,CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional skills; 3 group sessions where patients are going to learn how to identify, express and regulate their emotions	Behavioral: Emotional skills; 2-hour 3 group sessions; Other Names: Emotional intelligence
Sham Comparator: Relaxation and talking group; 3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer	Behavioral: Relaxation and talking group; 2-hour 3 group sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient emotional skills from baseline to 15 days after intervention	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)	Baseline and 15 days after the end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient emotional skills long term	Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score	T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)	Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)	Baseline (T0), 15 days after the end of the intervention (T1), 2 months
Patient participation in workshops	The percentage of patients who have attended the 3 group sessions	Between 2 weeks and 2 months
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
Patient satisfaction	Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire	T1 (15 days after the end of the intervention) and T2 (2 months after T1)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Santelys Association; SIRIC ONCOLille

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2017
• Primary Completion (Actual): May 7, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; Emotional Intelligence
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Diseases; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Thoracic Neoplasms
• Other Study ID Numbers: 2016_29; 2017-A00224-49 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No