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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03336905
Other study ID # PREVAPAJA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2016
Est. completion date April 2019

Study information

Verified date November 2017
Source Centre Leon Berard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 15 Years to 25 Years
Eligibility Inclusion Criteria:

- With neoplasms, histologically confirmed

- Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician, the referring physician or the physician investigator

- Covered by a medical insurance

- Written, signed informed consent

Exclusion Criteria:

- Cons-indication to physical activity practice, at discretion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity program and prevention after cancer
Providing a supervised and non-supervised physical activity program for adolescent and Young adult with cancer and improve awareness on cancer prevention recommendations (second cancer risk, healthy lifestyles...)

Locations

Country Name City State
France Centre Léon Bérard Lyon

Sponsors (1)

Lead Sponsor Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (2)

Carretier J, Boyle H, Duval S, Philip T, Laurence V, Stark DP, Berger C, Marec-Bérard P, Fervers B. A Review of Health Behaviors in Childhood and Adolescent Cancer Survivors: Toward Prevention of Second Primary Cancer. J Adolesc Young Adult Oncol. 2016 Jun;5(2):78-90. doi: 10.1089/jayao.2015.0035. Epub 2015 Dec 1. Review. — View Citation

Duval S, Carretier J, Boyle H, Philip T, Berger C, Marec-Bérard P, Fervers B. [Life style and occupational factors and prevention of second primary cancers after childhood and adolescent cancer: Current state of knowledge]. Bull Cancer. 2015 Jul-Aug;102(7-8):665-73. doi: 10.1016/j.bulcan.2015.03.017. Epub 2015 May 1. Review. French. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Score of physical activity International Physical Activity Questionnaire 12 months
Secondary Score of quality of life QLQC30 4 months
Secondary Score of fatigue Visual analogic scale 4 months
Secondary Weight 4 months
Secondary Waist circumference 4 months
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