Clinical Trials Directory

Trials / Completed

CompletedNCT04556344

Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALEmotional skills3 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.
BEHAVIORALShort free talk and relaxation3 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.

Timeline

Start date
2020-10-26
Primary completion
2023-01-05
Completion
2023-01-05
First posted
2020-09-21
Last updated
2025-12-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04556344. Inclusion in this directory is not an endorsement.