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

Digestive System Neoplasms Clinical Trial

— EmoVie_K  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03306693
• Other study ID #: 2016_29
• Secondary ID: 2017-A00224-49
• Status: Terminated
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: May 7, 2019

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 7, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Emotional skills
2-hour 3 group sessions
• Relaxation and talking group
2-hour 3 group sessions

Locations

Country	Name	City	State
France	Hôpital Calmette,CHU	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Santélys, SIRIC ONCOLille

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 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	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
Secondary	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
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 and ad hoc questionnaire	T1 (15 days after the end of the intervention) and T2 (2 months after T1)