Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

NCT ID: NCT02893774

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-12
• Study Completion Date: 2023-02-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

quality of life assessment

Intervention Type: 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)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CAMPONE Mario, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

ICO René Gauducheau

Nantes, , France

Countries

France

Other Identifiers

2014-A01675-42

Identifier Type: OTHER

Identifier Source: secondary_id

ICO-N-2014-10

Identifier Type: -

Identifier Source: org_study_id