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

NCT04556344 | Completed

• 2 other identifiers: 2019_692020-A00674-35
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Thoracic Neoplasms; Digestive System Neoplasms

Keywords

Emotional Intelligence; Quality of Life; cancer survivors; psychology; supportive care

Outcome Measures

Primary Outcomes (1)

• 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)

  Between Baseline (T0) and 15 days after the intervention (T1)

Secondary Outcomes (7)

• Patient emotional skills at follow up

  Between T0 (start of the intervention) and T2 (2 months after T1)

• Difficulties in Emotional Regulation

  Between T0 (baseline) and T1 (15 days after the end of the intervention) and between T1 and T2 (2 months after T1)

• Quality of life by FACT-G

  At T0 (before the first session), at T1 (15 days after the last session) and at T2 (2 months after T1).

• Change in quality of life using FACT-G

  Between T0 (baseline) and T1 (&5 days after the end of the intervention) and between T1 and T2 (2 months after T1)

• Patient participation in workshops

  Between 2 weeks and 2 months

Study Arms (2)

Emotional skills

EXPERIMENTAL

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

Behavioral: Emotional skills

Short free talk and relaxation

SHAM COMPARATOR

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.

Behavioral: Short free talk and relaxation

Interventions

Emotional skills 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.

Emotional skills

Short free talk and relaxation 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Lille: lead
• SCALab UMR CNRS 9193: collaborator

Study Sites (1)

Hôpital Calmette,CHU

Lille, France

Location

MeSH Terms

Conditions

Digestive System Neoplasms; Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Alexis Cortot, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 21, 2020
• Study Start: October 26, 2020
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: December 5, 2025

Record last verified: 2022-05

Locations

FR (1)