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

Sponsor

University Hospital, Lille (Other)

Overall Status

Terminated

CT.gov ID

NCT03306693

Collaborator

SIRIC ONCOLille (Other), Santelys Association (Other)

Enrollment

Location

Arms

18.3

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Neoplasms Thoracic Neoplasms	Behavioral: Emotional skills Behavioral: Relaxation and talking group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

23 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 Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management

Actual Study Start Date :

Oct 26, 2017

Actual Primary Completion Date :

May 7, 2019

Actual Study Completion Date :

May 7, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in patient emotional skills from baseline to 15 days after intervention [Baseline and 15 days after the end of the 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)

Secondary Outcome Measures

Patient emotional skills long term [T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months]
Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score
Quality of life by 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-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
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 and ad hoc questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).