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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03306693
Other study ID # 2016_29
Secondary ID 2017-A00224-49
Status Terminated
Phase N/A
First received
Last updated
Start date October 26, 2017
Est. completion date May 7, 2019

Study information

Verified date September 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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).

Study Design


Intervention

Behavioral:
Emotional skills
2-hour 3 group sessions
Relaxation and talking group
2-hour 3 group sessions

Locations

Country Name City State
France Hôpital Calmette,CHU Lille

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Lille Santélys, SIRIC ONCOLille

Country where clinical trial is conducted

France, 

Outcome

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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