Digestive System Neoplasms Clinical Trial
— EmoVie_KOfficial title:
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management
Verified date | September 2020 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | May 7, 2019 |
Est. primary completion date | May 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 informed consent to participate in the study. 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). |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Calmette,CHU | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | Santélys, SIRIC ONCOLille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patient emotional skills long term | Variation of patient-reported PEC (Profile of Emotional Competence) questionnaire score | T1 (15 days after the end of the intervention) and T2 (2 months after T1) : 2 months | |
Secondary | 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) | Baseline (T0), 15 days after the end of the intervention (T1), 2 months | |
Secondary | Patient participation in workshops | The percentage of patients who have attended the 3 group sessions | Between 2 weeks and 2 months | |
Secondary | Patient adherence to exercises to do at home between sessions | The percentage of patients who have performed the suggested exercises at home between sessions | Between 2 weeks and 2 months | |
Secondary | Patient satisfaction | Patient-reported satisfaction regarding the intervention using and ad hoc questionnaire | T1 (15 days after the end of the intervention) and T2 (2 months after T1) |
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