Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-04-18 @ 2:50 PM
Study NCT ID:
NCT02284061
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-11-03', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Context: Sport and physical activity during and after cancer treatment can improve fitness and social inclusion in adults. In children, although early studies show interesting results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children following a physical training program showed a significant improvement in endurance, muscle tone, overall self-esteem, sports skills and self-perceived strength. The investigators then want to evaluate the health of a group of children during treat cancer that physical activities adapted compared to children who did not practice.\n\nObjective: Measuring the impact of physical activity program on health of children and adolescents with cancer with improved physical, psychological health, social reintegration and reduced time hospitalization.\n\nMethod and Design: The study plans to include 90 children from the pediatric hematology - oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18 months.\n\nThis is a randomized controlled open trial open with a stratified distribution. Children will be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. - Arm B (Control - Delayed Program): the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. Each child integrates the physical program for a period of one year.\n\nRegardless of the randomization arm, the child performs the initial tests, the intermediate tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be performed at 3 and 9 months.\n\nThe physical activity program includes a minimum of 30 days of activities per 6 months (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.\n\nThe investigators aim at demonstrating a difference of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with malignant disease\n* Supported in service pediatric hematology-oncology child Timone hospital in Marseille.\n* Age ≥ 5 years and ≤ 19 years\n* No medical-cons to the practice of physical activity\n\nExclusion Criteria:\n\n* Life expectancy less than 18 months.\n* Inability to comply with follow-up study for geographical, social or psychological.\n* Length of stay less than 18 months, for children living outside mainland\n* Not understanding of the French language\n* Prior Participation in physical activity program'}, 'identificationModule': {'nctId': 'NCT02284061', 'briefTitle': 'Physical Activity Program in Children and Adolescents With Cancer : Assessment of Benefits on Physical, Psychological and Social Health.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2014-25'}, 'secondaryIdInfos': [{'id': 'APHM', 'type': 'OTHER', 'domain': 'RCAPHM14_0204'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'Immediate Program : the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits.', 'interventionNames': ['Other: physical activities adapted to children']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Delayed Program: the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months.', 'interventionNames': ['Other: physical activities adapted to children']}], 'interventions': [{'name': 'physical activities adapted to children', 'type': 'OTHER', 'armGroupLabels': ['Control', 'experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gérard Michel, MD', 'role': 'CONTACT', 'email': 'gerard.michel@ap-hm.fr'}], 'facility': 'Assistance publique hopitaux de marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Gérard MICHEL', 'role': 'CONTACT', 'email': 'gerard.michel@ap-hm.fr'}], 'overallOfficials': [{'name': 'Urielle DESALBRES', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}