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

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ClinicalTrials.gov Identifier: NCT03306693
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : June 27, 2019
Sponsor:
Collaborators:
SIRIC ONCOLille
Santélys
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Digestive System Neoplasms Thoracic Neoplasms Behavioral: Emotional skills Behavioral: Relaxation and talking group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 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 : October 26, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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 Name: 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




Primary Outcome Measures :
  1. Change in patient emotional skills from baseline to 15 days after intervention [ Time Frame: 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 :
  1. Patient emotional skills long term [ Time Frame: 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

  2. Quality of life by 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 ]
    Patient-reported health-related quality of life using the Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)

  3. Patient participation in workshops [ Time Frame: Between 2 weeks and 2 months ]
    The percentage of patients who have attended the 3 group sessions

  4. Patient adherence to exercises to do at home between sessions [ Time Frame: Between 2 weeks and 2 months ]
    The percentage of patients who have performed the suggested exercises at home between sessions

  5. Patient satisfaction [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306693


Contacts
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Contact: Alexis Cortot +33 3 20 44 49 98 alexis.cortot@chru-lille.fr
Contact: Eric Wasielewski +33 3 20 44 56 12 eric.wasielewski@chur-lille.fr

Locations
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France
Hôpital Calmette,CHU Recruiting
Lille, France
Contact: Alexis Cortot         
Principal Investigator: Alexis Cortot, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
SIRIC ONCOLille
Santélys

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03306693     History of Changes
Other Study ID Numbers: 2016_29
2017-A00224-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Emotional Intelligence
Quality of Life
Additional relevant MeSH terms:
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Digestive System Neoplasms
Gastrointestinal Neoplasms
Thoracic Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases