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OpenTrials
Completed

NCT Number: NCT03336905

Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs

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.

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Key information

Conditions

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity program and prevention after cancer

Other

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...)

Primary outcomes

  1. Score of physical activity

    Time frame: 12 months

    International Physical Activity Questionnaire

Secondary outcomes

  1. Score of quality of life

    Time frame: 4 months

    QLQC30

  2. Score of fatigue

    Time frame: 4 months

    Visual analogic scale

  3. Weight

    Time frame: 4 months

  4. Waist circumference

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for Teenagers and Young Adults With Cancer

Acronym: PREVAPAJA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2017
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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