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

Not Applicable

Terminated

• Conditions: Digestive System Neoplasms; Thoracic Neoplasms
• Interventions: Behavioral: Relaxation and talking group; Behavioral: Emotional skills

• Registration Number: NCT03306693
• Lead Sponsor: University Hospital, Lille

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.

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 Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-11
• Study Start: 2017-10-26
• Primary Completion: 2019-05-07
• Study Completion: 2019-05-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation and talking group	Relaxation and talking group	3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer
Emotional skills	Emotional skills	3 group sessions where patients are going to learn how to identify, express and regulate their emotions

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 participation in workshops	Between 2 weeks and 2 months	The percentage of patients who have attended the 3 group sessions
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
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
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)

Trial Locations

Locations (1)

Hôpital Calmette,CHU; 🇫🇷 Lille, France