Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer (EmoVie_K2)
Primary Purpose
Digestive System Neoplasms, Thoracic Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Emotional skills
Short free talk and relaxation
Sponsored by
About this trial
This is an interventional supportive care trial for Digestive System Neoplasms focused on measuring Emotional Intelligence, Quality of Life, cancer survivors, psychology, supportive care
Eligibility Criteria
Inclusion Criteria:
- Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
- Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
- Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
- Affiliation to a social security scheme,
- Mastery of the French language,
- Signing of informed consent to participate in this research.
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 psychotherapeutic follow-up))
- Patients under judicial protection (guardianship or curators).
Sites / Locations
- Hôpital Calmette,CHURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Emotional skills
Short free talk and relaxation
Arm Description
3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions
3 individual sessions in which patients are going to follow relaxation instructions after a non-directive talk about their current or past experience of cancer.
Outcomes
Primary Outcome Measures
Change in patient emotional skills from baseline to 15 days after the end of intervention
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)
Secondary Outcome Measures
Patient emotional skills at follow up
Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).
Difficulties in Emotional Regulation
Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.
Quality of life by FACT-G
Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Change in quality of life using FACT-G
Variation in assessed quality of life (FACT-G) between T0 and T1 and between T1 and T2 based on variation in emotional competence (13-item S-PEC)
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 ad hoc questionnaire
Full Information
NCT ID
NCT04556344
First Posted
September 8, 2020
Last Updated
July 4, 2022
Sponsor
University Hospital, Lille
Collaborators
SCALab UMR CNRS 9193
1. Study Identification
Unique Protocol Identification Number
NCT04556344
Brief Title
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer
Acronym
EmoVie_K2
Official Title
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
SCALab UMR CNRS 9193
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
Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the 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, cancer survivors, psychology, supportive care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emotional skills
Arm Type
Experimental
Arm Description
3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions
Arm Title
Short free talk and relaxation
Arm Type
Sham Comparator
Arm Description
3 individual sessions in which patients are going to follow relaxation instructions after a non-directive talk about their current or past experience of cancer.
Intervention Type
Behavioral
Intervention Name(s)
Emotional skills
Intervention Description
3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
Intervention Type
Behavioral
Intervention Name(s)
Short free talk and relaxation
Intervention Description
3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
Primary Outcome Measure Information:
Title
Change in patient emotional skills from baseline to 15 days after the end of intervention
Description
Variation in patient-reported 13-item Short Profile of Emotional Competence (S-PEC) score from baseline (T0) to 15 days after the intervention (T1)
Time Frame
Between Baseline (T0) and 15 days after the intervention (T1)
Secondary Outcome Measure Information:
Title
Patient emotional skills at follow up
Description
Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).
Time Frame
Between T0 (start of the intervention) and T2 (2 months after T1)
Title
Difficulties in Emotional Regulation
Description
Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.
Time Frame
Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)
Title
Quality of life by FACT-G
Description
Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Time Frame
At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).
Title
Change in quality of life using FACT-G
Description
Variation in assessed quality of life (FACT-G) between T0 and T1 and between T1 and T2 based on variation in emotional competence (13-item S-PEC)
Time Frame
Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)
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 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:
Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
Affiliation to a social security scheme,
Mastery of the French language,
Signing of informed consent to participate in this research.
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 psychotherapeutic follow-up))
Patients under judicial protection (guardianship or curators).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Cortot, MD,PhD
Phone
+33 3 20 44 49 98
Email
alexis.cortot@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Wasielewski
Phone
+33 3 20 44 56 12
Email
eric.wasielewski@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Cortot, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Calmette,CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Lelorain, PhD
Phone
(0)3 20 41 69 68
Ext
+33
Email
sophie.lelorain@univ-lille.fr
First Name & Middle Initial & Last Name & Degree
Christelle Duprez, PhD
Phone
(0) 3 20 41 72 12
Ext
+33
Email
christelle.duprez@univ-lille.fr
First Name & Middle Initial & Last Name & Degree
Alexis Cortot, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer
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