ClinicalTrials.gg
TerminatedNCT03306693EmoVie_KUpdated Sep 10, 2020

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

An interventional study of Emotional skills and Relaxation and talking group in Digestive System Neoplasms and Thoracic Neoplasms, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Supportive care

Why this study was terminated
insufficient inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Digestive System Neoplasms with a site in France — 5 open to participants now, 7 under way, 1 of them phase 3. Digestive System Neoplasms · France.

Enrollment
22nd of 26
23 · median 109
Started
2017
with 2 others
No phase
7 of 31
1 open now
Registered
20th of 31
by date
Lead sponsor
2 of 31
University Hospital, Lille

Among the 31 studies in Digestive System Neoplasms with a site in France, this one is the 22nd largest by enrollment of the 26 interventional ones that give a count, is one of 3 that started in 2017, is one of 7 with no phase, and was the 20th registered.

Digestive System Neoplasms

195 studies on the registry are indexed under Digestive System Neoplasms; 57 are open to participants now.

Browse Digestive System Neoplasms studies →

Open to participants now

5 of the 31 studies in Digestive System Neoplasms with a site in France are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 52 Digestive System Neoplasms studies recruiting now, 27 (52%) set no upper age limit and 17 (33%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Digestive System Neoplasms with a site in France, or all of them as a file.
02

Study 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.

Read the 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).

03

Conditions studied

  • Digestive System Neoplasms
  • Thoracic Neoplasms

Keywords

  • Emotional Intelligence
  • Quality of Life
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study.

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Emotional skills

    3 group sessions where patients are going to learn how to identify, express and regulate their emotions

    Behavioral: Emotional skills

  • 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

Interventions

  • BehavioralEmotional skills

    2-hour 3 group sessions

    Also known as: Emotional intelligence

  • BehavioralRelaxation and talking group

    2-hour 3 group sessions

06

What researchers measure

Primary outcomes

  1. Change in patient emotional skills from baseline to 15 days after 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)

    Time frame: Baseline and 15 days after the end of the intervention

Secondary outcomes

  1. Patient emotional skills long term

    Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score

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

  2. Quality of life by Medical Outcome Study Health Survey Short Form-36 (MOS SF-36)

    Patient-reported health-related quality of life using the 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

  3. Patient participation in workshops

    The percentage of patients who have attended the 3 group sessions

    Time frame: Between 2 weeks and 2 months

  4. Patient adherence to exercises to do at home between sessions

    The percentage of patients who have performed the suggested exercises at home between sessions

    Time frame: Between 2 weeks and 2 months

  5. Patient satisfaction

    Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire

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

07

Study locations

1 site
  • Hôpital Calmette,CHU
    Lille, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in May 2019, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 11, 2017
StartActual
Oct 26, 2017
Primary completionActual
May 7, 2019
CompletionActual
May 7, 2019
Last update
Sep 10, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03306693
Collaborators
SIRIC ONCOLille, Santelys Association
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Oct 26, 2017
Primary completion
May 7, 2019
Completion
May 7, 2019
Last update
Sep 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion