NCT03336905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

November 1, 2017

Enrollment Period

2.4 years

First QC Date

October 30, 2017

Last Update Submit

September 3, 2019

Conditions

Neoplasms

Keywords

Adolescent and young adult

Outcome Measures

Primary Outcomes (1)

  • Score of physical activity

    International Physical Activity Questionnaire

    12 months

Secondary Outcomes (4)

  • Score of quality of life

    4 months

  • Score of fatigue

    4 months

  • Weight

    4 months

  • Waist circumference

    4 months

Study Arms (1)

Physical Activity and Prevention

EXPERIMENTAL

* 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

Interventions

Physical activity program and prevention after cancerOTHER

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...)

Physical Activity and Prevention

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (2)

  • 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.

    PMID: 26812458BACKGROUND

  • 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.

    PMID: 25936990BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Perrine MAREC-BERARD, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 8, 2017

Study Start

November 9, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

September 4, 2019

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)