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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
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms focused on measuring Adolescent and young adult

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 30, 2017
Last Updated
September 3, 2019
Sponsor
Centre Leon Berard
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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
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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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