Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer (ELCCA-II)

August 1, 2024 updated by: Institut Cancerologie de l'Ouest

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44805
        • Ico Rene Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cancer quality of life
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after initial cancer diagnostics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: CAMPONE Mario, Pr, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2015

Primary Completion (Actual)

February 20, 2023

Study Completion (Actual)

February 20, 2023

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimated)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-N-2014-10
  • 2014-A01675-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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