Breast CancerELCCA-IINCT02893774
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
A study testing quality of life assessment in people with Breast Cancer and Melanoma, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Melanoma
- What is being tested?
- quality of life assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2015to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of cancer (breast or melanoma) since less than 1 month
- no metastasis
- Inform Consent Form signed
Who cannot join
- severe psychiatric disorder (depression, psychosis, etc.)
- addictive pathology
- longtime antidepressant treatment (> 3 months)
- Patient pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- quality of life assessment
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life assessmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years after initial cancer diagnostics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start12 Mar 2015
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAMPONE Mario, Pr, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893774
- Sponsor's protocol ID
- ICO-N-2014-10
- Other IDs
- 2014-A01675-42
- Acronym
- ELCCA-II
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2016
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer
- ClinicalTrials.gov ID
- NCT02893774
- Acronym / sponsor ID
- ELCCA-II / ICO-N-2014-10
- Conditions
- Breast Cancer, Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer quality of life | Experimental | Other: quality of life assessmentAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of cancer (breast or melanoma) since less than 1 month
- no metastasis
- Inform Consent Form signed
Key exclusion criteria (4 listed)
- severe psychiatric disorder (depression, psychosis, etc.)
- addictive pathology
- longtime antidepressant treatment (> 3 months)
- Patient pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life assessmentAll 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) | Other | cancer quality of life |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAMPONE Mario, Pr principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life assessment in people with Breast Cancer and Melanoma, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long term evolution of quality of life for patient with breast cancer or melanoma (time frame: 5 years after initial cancer diagnostics). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.