- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06215365
Study of Health-risk Behaviours (Tobacco, Alcohol or Drug Consumption ; Nutrition ; Sedentary Lifestyle ; Sexual Practices) Among Cancer Survivors (PREVAC)
- Cancer is now becoming a chronic condition though it was, until a short time ago, a fatal illness. Thus, according to the French national cancer institute, nearly 4 million French people have been diagnosed with cancer in their lifetime.
- Screening is used to detect the presence of a pathology at an early, infra-clinical stage, or the presence of a risk factor in people who are supposedly healthy.
- There are three organized screening programs in France (breast cancer, colorectal cancer, cervical cancer), as well as many others recommended by learned societies such as the National Authority for Health . However, they are underused, far from European recommendations and government targets.
- According to DREES (research, studies, evaluation and statistic department), public health and primary prevention interventions could have prevented 143 deaths per 100.000 inhabitants, and healthcare interventions could have spared 59 deaths per 100.000 inhabitants, for a total of 202 avoidable deaths per 100.000 inhabitants in France in 2020.
- As for cancers, French national cancer institute estimates the rate of avoidable cancers in France in 2023 at 40%. Breast cancer, for example, is the most common cancer that can be associated with alcohol consumption and estimations suggest that nearly 20.000 breast cancers could be prevented each year (a third of new cancer cases in 2018).
- In France, prevention accounts for 5.5% of healthcare expenses in 2021, with 46% for individual primary prevention, 41% for individual secondary prevention and 12% for collective prevention and prevention programs. These healthcare expenses must be set against the social cost of each risk factor, to see how important they are.
- Relative burden of cancer and noncancer mortality among long-term survivors of breast, prostate, and colorectal cancer in the US has been demonstrated. It shows that "patients with low oncologic risk at the time of diagnosis had at least 3-fold higher risk of noncancer death compared with death from the index cancer".
- In France, medical desertification is a reality. Now, according to the VICAN-5 study, nearly a third of cancer patients are not followed up by general practitioners. Though primary prevention is one of GP's prerogatives and a governmental priority.
- There is a high interest in screening and preventive action to limit the risk of other avoidable pathologies, whether cancerous or not.
The research hypothesis is that a customized screening will enable the implementation of comprehensive preventive action to limit the onset of avoidable diseases (second cancer or other pathology) for cancer survivors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69003
- Hospices Civils De Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cancer survivor
- Up to 74 years old
- Less than a year from the end of their heavy treatments
- Participating in JUMP post-cancer day.
Exclusion Criteria:
- Patients with cognitive disorders that limit their ability to understand and complete the questionnaire.
- Patients who do not speak, read and write French.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adult cancer survivors (until 74 years old) who have completed their heavy treatments
Adult cancer survivors (until 74 years old) who have completed their heavy treatments (chemotherapy, radio-chemotherapy, …) and that are taking part in the "JUMP post-cancer day" which is a multidisciplinary evaluation carried out at the end of treatments. They must not have cognitive disorders that limit their ability to understand and complete the questionnaire. Also, they have to speak, read and write French language. The study will be presented to the patient who can refuse to participate. The digital version of the questionnaire will be handed out, if the patient does not object after a period of thinking, when he or she comes to the day hospital for his or her JUMP Day. The study will therefore take place at a single point in time, and no pre-inclusion or follow-up visits are planned as part of this protocol. Completing the questionnaire takes about 15 to 20 minutes. All questions are designed to meet the stated objectives. No personally identifiable data is collected. |
The study will be presented to the patient who can refuse to participate. The digital version of the questionnaire will be handed out, if the patient does not object after a period of thinking, when he or she comes to the day hospital for his or her JUMP Day. The study will therefore take place at a single point in time, and no pre-inclusion or follow-up visits are planned as part of this protocol. Completing the questionnaire takes about 15 to 20 minutes. All questions are designed to meet the stated objectives. No personally identifiable data is collected. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The percentage of people in the studied population with at least one modifiable health risk behavior among cancer survivors.
Time Frame: through study completion, an average of 2 months
|
Modifiable health risk behaviors are: tobacco, alcohol or drug consumption ; nutrition ; sedentary lifestyle ; sexual practices.
|
through study completion, an average of 2 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- STOLTZ Justine. Mise en place d'une intervention d'évaluation des comportements à risques et de dépistage dans l'après-cancer (CO5). Congrès PARKOURS onco-hémato 2025, Auditorium Pasteur, jeudi 30 janvier 2025, 17:45-18:00 (Lyon).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL23_1306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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