Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 1:50 AM
Study NCT ID:
NCT05493150
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antalgic Effects of Well-being Treatments in Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assesment', 'timeFrame': '1 immediately before well being treatment', 'description': 'numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."'}, {'measure': 'Pain assesment', 'timeFrame': '1 immediately after well being treatment', 'description': 'numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Cancer Pain']}, 'descriptionModule': {'briefSummary': 'observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.', 'detailedDescription': 'Contrary to supportive care, well-being care is imperfectly assessed. Well being care (WBC) consist on complementary programs, with no real consensus. Very few studies have rigorously evaluated its benefits\n\nThe objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, Sophrology and singing) provided in a healthcare facility'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated for a cancer in CH Valence, agree to participate on one of the 4 Well being treatments: foot reflexology, socio-aesthetics, sophrology and singing', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all type of cancer treated at the general Hospital of Valence\n* patient agree to participate on Well being session: foot reflexology, socio-aesthetics, Sophrology and singing\n* Age ≥ 18 years\n* Affiliation to a Social security system\n* Patient who has given written consent signed before any specific procedure of the protocol\n\nExclusion Criteria:\n\n* Patient under guardianship, deprived of liberty, safeguard of justice\n* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator)\n* Refusal to participate in research'}, 'identificationModule': {'nctId': 'NCT05493150', 'acronym': 'Well Being', 'briefTitle': 'Antalgic Effects of Well-being Treatments in Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Valence'}, 'officialTitle': 'Antalgic Effects of Well-being Treatments in Cancer Care; Foot Reflexology, Socio-aesthetics, Sophrology, Singing', 'orgStudyIdInfo': {'id': 'RIPH-CHV-04'}}, 'contactsLocationsModule': {'locations': [{'zip': '26953', 'city': 'Valence', 'state': 'Drome', 'country': 'France', 'facility': 'Ch Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Valence', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}