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Completed

NCT Number: NCT04556344

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

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.

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Key information

Conditions

Digestive System Neoplasms Digestive System Diseases Neoplasms Neoplasms by Site Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Calmette,CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in patient emotional skills from baseline to 15 days after the end of intervention

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

    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 outcomes

  1. Patient emotional skills at follow up

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

    Variation in the emotional competence score (13-item S-PEC) between Baseline (T0) and T2 (2.5 months after the last session).

  2. Difficulties in Emotional Regulation

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

    Variation in the Difficulties in Emotional Regulation Scale (DERS 16) score between T0 and T1 and between T1 and T2.

  3. Quality of life by FACT-G

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

    Patients' self-reported quality of life assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire

  4. Change in quality of life using FACT-G

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

    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)

  5. Patient participation in workshops

    Time frame: Between 2 weeks and 2 months

    The percentage of patients who have attended the 3 group sessions

  6. 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

  7. 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 ad hoc questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • SCALab UMR CNRS 9193

Registry information

Official study 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)

Acronym: EmoVie_K2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2020
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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