Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs (PREVAPAJA)
Primary Purpose
Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity program and prevention after cancer
Sponsored by
About this trial
This is an interventional prevention trial for Neoplasms focused on measuring Adolescent and young adult
Eligibility Criteria
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
Sites / Locations
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physical Activity and Prevention
Arm Description
co-construction of supervised and non-supervised physical activity sessions with a physical activity trainer balance sheet (at diagnosis and 4 monthes+/- 2 months later) : IPAQ, QLQC30, 6-min walk test, anthropometric evaluation meetings and phone calls after the physical activity program to assess patient perception and satisfaction, and provide information and recommendations for cancer prevention
Outcomes
Primary Outcome Measures
Score of physical activity
International Physical Activity Questionnaire
Secondary Outcome Measures
Score of quality of life
QLQC30
Score of fatigue
Visual analogic scale
Weight
Waist circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03336905
Brief Title
Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs
Acronym
PREVAPAJA
Official Title
Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for Teenagers and Young Adults With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Adolescent and young adult
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity and Prevention
Arm Type
Experimental
Arm Description
co-construction of supervised and non-supervised physical activity sessions with a physical activity trainer
balance sheet (at diagnosis and 4 monthes+/- 2 months later) : IPAQ, QLQC30, 6-min walk test, anthropometric evaluation
meetings and phone calls after the physical activity program to assess patient perception and satisfaction, and provide information and recommendations for cancer prevention
Intervention Type
Other
Intervention Name(s)
Physical activity program and prevention after cancer
Intervention Description
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 Outcome Measure Information:
Title
Score of physical activity
Description
International Physical Activity Questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Score of quality of life
Description
QLQC30
Time Frame
4 months
Title
Score of fatigue
Description
Visual analogic scale
Time Frame
4 months
Title
Weight
Time Frame
4 months
Title
Waist circumference
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrine MAREC-BERARD, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26812458
Citation
Carretier J, Boyle H, Duval S, Philip T, Laurence V, Stark DP, Berger C, Marec-Berard 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.
Results Reference
background
PubMed Identifier
25936990
Citation
Duval S, Carretier J, Boyle H, Philip T, Berger C, Marec-Berard 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. French.
Results Reference
background
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Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for TYACs
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