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

NCT ID: NCT04556344

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2023-01-05

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.

Conditions

Digestive System Neoplasms; Thoracic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Emotional skills

3 individual sessions in which patients are going to learn how to identify, understand, express and regulate emotions

Group Type: EXPERIMENTAL

Emotional skills

Intervention Type: BEHAVIORAL

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.

Short free talk and relaxation

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.

Group Type: SHAM_COMPARATOR

Short free talk and relaxation

Intervention Type: BEHAVIORAL

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.

Interventions

Emotional skills

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

Short free talk and relaxation

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SCALab UMR CNRS 9193

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexis Cortot, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Calmette,CHU

Lille, , France

Countries

France

Other Identifiers

2020-A00674-35

Identifier Type: OTHER

Identifier Source: secondary_id

2019_69

Identifier Type: -

Identifier Source: org_study_id