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

Primary Purpose

Breast Cancer, Melanoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
quality of life assessment
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ICO René Gauducheau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cancer quality of life

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2016
Last Updated
July 31, 2023
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT02893774
Brief Title
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Acronym
ELCCA-II
Official Title
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Melanoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cancer quality of life
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
quality of life assessment
Intervention Description
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 Outcome Measure Information:
Title
long term evolution of quality of life for patient with breast cancer or melanoma
Description
The evolution of quality of life will be assess with standardized quality of life questionnaire
Time Frame
5 years after initial cancer diagnostics

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAMPONE Mario, Pr
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

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