Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00170235
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-03', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'participation restriction', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Prehabilitation', 'Rehabilitation', 'Exercise'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '11338798', 'type': 'BACKGROUND', 'citation': 'Mayo NE, Scott SC, Shen N, Hanley J, Goldberg MS, MacDonald N. Waiting time for breast cancer surgery in Quebec. CMAJ. 2001 Apr 17;164(8):1133-8.'}, {'pmid': '14668668', 'type': 'BACKGROUND', 'citation': 'Shen N, Mayo NE, Scott SC, Hanley JA, Goldberg MS, Abrahamowicz M, Tamblyn R. Factors associated with pattern of care before surgery for breast cancer in Quebec between 1992 and 1997. Med Care. 2003 Dec;41(12):1353-66. doi: 10.1097/01.MLR.0000100581.88722.6C.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this pilot study is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery.', 'detailedDescription': 'Breast cancer surgery is one of the most frightening health events a woman can experience. Not only is there fear of cancer and mortality, but also fear of disfigurement and disability arising from the surgery and from the subsequent chemotherapy and radiotherapy. The pre-operative period is a time of great anxiety and in the post-operative period this anxiety is compounded by pain and discomfort associated with the breast and axillary wounds. Lack of knowledge about follow-up treatment leads to fear and anxiety post-surgery. All women experience loss of mobility and function of the arm on the operative side for a period of time ranging from days to months to years. This arm morbidity interferes with participation in usual activities, is an additional source of stress compounding the psychological distress associated with the cancer itself, and has a negative impact on the quality of life.\n\nThe post-operative period may not be the most opportune time to introduce interventions to accelerate recovery. Many women will be concerned about perturbing the healing process and may be depressed and anxious as they await extra treatment for the tumor. The pre-operative period may be a more emotionally salient time to intervene in the factors that contribute to recovery.\n\nThe process of enhancing functional capacity of the individual to enable him or her to withstand stressors is termed "prehabilitation". This project deals with the effectiveness of prehabilitation with or without post-operative exercise to reduce arm morbidity and increase quality of life following breast cancer surgery.\n\nThe overall aim is to explore the feasibility of a randomized trial to test the effectiveness of physical therapy, provided both pre- and post-surgery, on reducing arm morbidity and increasing health-related quality of life (HRQL) post-surgery. The specific objectives of this pilot project are to:\n\n1. estimate recruitment rates for such a trial;\n2. estimate compliance to the protocols;\n3. pilot the randomization procedures;\n4. identify sub-groups of the population with different needs for pre-and post-surgical physical therapy;\n5. estimate effect sizes to be used for sample size calculations for the main project and for budget justification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Diagnosed with breast cancer\n* Able to complete questionnaires\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00170235', 'briefTitle': 'Reducing Arm Morbidity in Pre- and Post-breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'Reducing Arm Morbidity Through Physical Therapy Provided Pre- and Post-breast Cancer Surgery', 'orgStudyIdInfo': {'id': 'SDR-05-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Prehabilitation (exercises pre surgery)', 'interventionNames': ['Other: Prehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Usual care as provided by the institution', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'OTHER', 'description': 'Exercise class pre-surgery', 'armGroupLabels': ['1']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Exercise booklet, physiotherapy if needed', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A 1A1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Division of Clinical Epidemiology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Nancy Mayo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'James McGill Professor, Department of Medicine, School of Physical and Occupational Therapy, McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Breast Cancer Research Alliance', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Nancy Mayo', 'oldOrganization': 'McGill University'}}}}