NCT03306693

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

October 26, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

October 4, 2017

Last Update Submit

September 8, 2020

Conditions

Digestive System NeoplasmsThoracic Neoplasms

Keywords

Emotional IntelligenceQuality of Life

Outcome Measures

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)

    Baseline and 15 days after the end of the intervention

Secondary Outcomes (5)

  • Patient emotional skills long term

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

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

    Baseline (T0), 15 days after the end of the intervention (T1), 2 months

  • Patient participation in workshops

    Between 2 weeks and 2 months

  • Patient adherence to exercises to do at home between sessions

    Between 2 weeks and 2 months

  • Patient satisfaction

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

Study Arms (2)

Emotional skills

EXPERIMENTAL

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

Behavioral: Emotional skills

Relaxation and talking group

SHAM COMPARATOR

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

Emotional skillsBEHAVIORAL

2-hour 3 group sessions

Also known as: Emotional intelligence
Emotional skills
Relaxation and talking groupBEHAVIORAL

2-hour 3 group sessions

Relaxation and talking group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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 informed consent to participate in the study.

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 psychotherapy )
  • Patients under judicial protection (guardianship or curators).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Calmette,CHU

Lille, France

Location

MeSH Terms

Conditions

Digestive System NeoplasmsThoracic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System Diseases

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

October 4, 2017

First Posted

October 11, 2017

Study Start

October 26, 2017

Primary Completion

May 7, 2019

Study Completion

May 7, 2019

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

FR(1)