Breast Cancer Clinical Trial
— ELCCA-IIOfficial title:
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Verified date | July 2023 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Generally, French studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). However, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). These studies mainly concern the most common cancers (breast and prostate). Or changes in quality of life after treatment could be different depending on the type of cancer. In addition, there is a significant influence of sociodemographic variables on the quality of life in remission. Similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process. Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.
Status | Completed |
Enrollment | 314 |
Est. completion date | February 20, 2023 |
Est. primary completion date | February 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - diagnosis of cancer (breast or melanoma) since less than 1 month - no metastasis - Inform Consent Form signed Exclusion Criteria: - severe psychiatric disorder (depression, psychosis, etc.) - addictive pathology - longtime antidepressant treatment (> 3 months) - Patient pregnant or breastfeeding |
Country | Name | City | State |
---|---|---|---|
France | ICO René Gauducheau | Nantes |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | long term evolution of quality of life for patient with breast cancer or melanoma | The evolution of quality of life will be assess with standardized quality of life questionnaire | 5 years after initial cancer diagnostics |
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