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CompletedNCT02893774ELCCA-IIUpdated Aug 2, 2024

Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

An interventional study of quality of life assessment in Breast Cancer and Melanoma, sponsored by Institut Cancerologie de l'Ouest. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Institut Cancerologie de l'Ouest · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Mar 2015, registered Aug 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
314
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Breast Cancer
  • Melanoma

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In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 314 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Institut Cancerologie de l'Ouest is the lead sponsor of 105 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of cancer (breast or melanoma) since less than 1 month
  • no metastasis
  • Inform Consent Form signed

Exclusion criteria

Exclusion Criteria:

  • severe psychiatric disorder (depression, psychosis, etc.)
  • addictive pathology
  • longtime antidepressant treatment (> 3 months)
  • Patient pregnant or breastfeeding
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
314 participants (actual)

Study arms

  • 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

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)

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years after initial cancer diagnostics

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Study locations

1 site
  • ICO René Gauducheau
    Nantes, 44805, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02893774
Lead sponsor
Institut Cancerologie de l'Ouest
Responsible party
Sponsor
First posted
Sep 8, 2016
Start date
Mar 12, 2015
Primary completion
Feb 20, 2023
Completion
Feb 20, 2023
Last update
Aug 2, 2024

Study contacts

CAMPONE Mario, Pr
principal investigator · Institut de Cancérologie de l'Ouest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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