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Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02893774
Acronym
ELCCA-II
Enrollment
314
Registered
2016-09-08
Start date
2015-03-12
Completion date
2023-02-20
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Melanoma

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.

Interventions

OTHERquality 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)

Sponsors

Institut Cancerologie de l'Ouest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
long term evolution of quality of life for patient with breast cancer or melanoma5 years after initial cancer diagnosticsThe evolution of quality of life will be assess with standardized quality of life questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026