Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Not Applicable

Completed

• Conditions: Melanoma; Breast Cancer
• Interventions: Other: quality of life assessment

• Registration Number: NCT02893774
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-02
• Study First Posted: 2016-09-08
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cancer quality of life	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

Primary Outcome Measures

Name	Time	Method
long term evolution of quality of life for patient with breast cancer or melanoma	5 years after initial cancer diagnostics	The evolution of quality of life will be assess with standardized quality of life questionnaire

Trial Locations

Locations (1)

ICO René Gauducheau; 🇫🇷 Nantes, France