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NCT Number: NCT02893774

Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICO René Gauducheau

Nantes, 44805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Assessment

Other

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)

Primary outcomes

  1. long term evolution of quality of life for patient with breast cancer or melanoma

    Time frame: 5 years after initial cancer diagnostics

    The evolution of quality of life will be assess with standardized quality of life questionnaire

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: ELCCA-II

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2016
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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