Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

NCT02893774 | Completed

• 2 other identifiers: ICO-N-2014-102014-A01675-42
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Melanoma

Outcome Measures

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

  5 years after initial cancer diagnostics

Study Arms (1)

cancer quality of life

EXPERIMENTAL

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

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)

cancer quality of life

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

ICO René Gauducheau

Nantes, 44805, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• CAMPONE Mario, Pr

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 8, 2016
• Study Start: March 12, 2015
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)