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

Primary Purpose

Digestive System Neoplasms, Thoracic Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Emotional skills
Relaxation and talking group
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Digestive System Neoplasms focused on measuring Emotional Intelligence, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Hôpital Calmette,CHU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Emotional skills

Relaxation and talking group

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Patient emotional skills long term
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)
Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Patient participation in workshops
The percentage of patients who have attended the 3 group sessions
Patient adherence to exercises to do at home between sessions
The percentage of patients who have performed the suggested exercises at home between sessions
Patient satisfaction
Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire

Full Information

First Posted
October 4, 2017
Last Updated
September 8, 2020
Sponsor
University Hospital, Lille
Collaborators
SIRIC ONCOLille, Santelys Association
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1. Study Identification

Unique Protocol Identification Number
NCT03306693
Brief Title
Educational Intervention to Increase the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
insufficient inclusions
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
SIRIC ONCOLille, Santelys Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Neoplasms, Thoracic Neoplasms
Keywords
Emotional Intelligence, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional skills
Arm Type
Experimental
Arm Description
3 group sessions where patients are going to learn how to identify, express and regulate their emotions
Arm Title
Relaxation and talking group
Arm Type
Sham Comparator
Arm Description
3 group sessions where patients are going to follow relaxation instructions and after a non directive talking group about cancer
Intervention Type
Behavioral
Intervention Name(s)
Emotional skills
Other Intervention Name(s)
Emotional intelligence
Intervention Description
2-hour 3 group sessions
Intervention Type
Behavioral
Intervention Name(s)
Relaxation and talking group
Intervention Description
2-hour 3 group sessions
Primary Outcome Measure Information:
Title
Change in patient emotional skills from baseline to 15 days after intervention
Description
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)
Time Frame
Baseline and 15 days after the end of the intervention
Secondary Outcome Measure Information:
Title
Patient emotional skills long term
Description
Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score
Time Frame
T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months
Title
Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Description
Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)
Time Frame
Baseline (T0), 15 days after the end of the intervention (T1), 2 months
Title
Patient participation in workshops
Description
The percentage of patients who have attended the 3 group sessions
Time Frame
Between 2 weeks and 2 months
Title
Patient adherence to exercises to do at home between sessions
Description
The percentage of patients who have performed the suggested exercises at home between sessions
Time Frame
Between 2 weeks and 2 months
Title
Patient satisfaction
Description
Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire
Time Frame
T1 (15 days after the end of the intervention) and T2 (2 months after T1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Hôpital Calmette,CHU
City
Lille
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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