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

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Other: Physical activity program and prevention after cancer

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical Activity and Prevention; 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

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...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of physical activity	International Physical Activity Questionnaire	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of quality of life	QLQC30	4 months
Score of fatigue	Visual analogic scale	4 months
Weight		4 months
Waist circumference		4 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Perrine MAREC-BERARD, MD, Centre Léon Bérard

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Adolescent and young adult
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: PREVAPAJA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No