Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Breast Cancer Clinical Trial

— ELCCA-II  

Official title:

Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893774
• Other study ID #: ICO-N-2014-10
• Secondary ID: 2014-A01675-42
• Status: Completed
• Phase: N/A
• Start date: March 12, 2015
• Est. completion date: February 20, 2023

Study information

• Verified date: July 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Melanoma

Intervention

Other:
• quality of life assessment
All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis. Those assessment will use standardized quality of life questionnaire : QLQ-C30 SWLS (Satisfaction with Life Scale) PTGI (Post-Traumatic Growth Inventory) HADS (Hospital Anxiety and Depression Scale) Brief COPE MHLCS (Multidimensional Health Locus of Control Scale)

Locations

Country	Name	City	State
France	ICO René Gauducheau	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

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