Breast CancerNCT00462410
Effect of Advertisements on Treatment Compliance in Women With Breast Cancer
A study testing counseling intervention and psychosocial assessment and care in people with Breast Cancer, run by Institut Bergonié.
Trial summary
RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment. PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- counseling intervention and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to May 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Socio-anthropological Study Evaluating the Impact of Observance or Treatment in Patients With Breast Cancer
RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the consequences of advertisement on treatment compliance in women with breast cancer.
Secondary
- Determine the factors favoring or not favoring adherence to the medical recommendations.
OUTLINE: Patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. The first interview is at the consultation visit and the second interview is at the patient's home. The impact of advertisement on treatment compliance is measured.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- counseling intervention, psychosocial assessment and care
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
psychosocial assessment and careProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment compliance
Secondary outcomes (1)
Factors affecting adherence to the medical plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startMar 2006
- Primary completionMay 2011
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
- Health services research
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Investigators
- Marc Debled, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462410
- Sponsor's protocol ID
- CDR0000540528
- Other IDs
- IB-2006-03, INCA-REF0145, INCA-SOCIO-ANTHROPO
- Status last verified
- May 2011
- First submitted
- 18 Apr 2007
- Last updated
- 23 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socio-anthropological Study Evaluating the Impact of Observance or Treatment in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00462410
- Acronym / sponsor ID
- CDR0000540528
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- May 2011 (actual)
- First posted
- 19 Apr 2007 (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.
RATIONALE: Measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the consequences of advertisement on treatment compliance in women with breast cancer.
Secondary
- Determine the factors favoring or not favoring adherence to the medical recommendations.
OUTLINE: Patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. The first interview is at the consultation visit and the second interview is at the patient's home. The impact of advertisement on treatment compliance is measured.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Study design
- Primary purpose
- Health services research
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| counseling intervention | Other | – |
| psychosocial assessment and care | Procedure or surgery | – |
Primary outcome
Treatment compliance
1 secondary outcome
Factors affecting adherence to the medical plan
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 23 Jan 2012.
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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.
Marc Debled, MD study chair
Institut Bergonié
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention and psychosocial assessment and care in people with Breast Cancer, run by Institut Bergonié.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Treatment compliance. 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 23 Jan 2012.