Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04731805
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2021-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Moving On - An RCT to Test Physical Therapy Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial, longitudinal and prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2015-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2021-01-24', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in active shoulder range of motion', 'timeFrame': '3 months', 'description': 'Active shoulder range of motion is measured with a standard goniometer in degrees. Change from baseline to 3 months for shoulder flexion, extension, abduction, and internal and external ranges are measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Warren C. Physical therapy intervention suggestions for women following breast cancer surgery. Journal of Women's Health Physical Therapy. 2005;29(1):21-24."}, {'pmid': '19831159', 'type': 'BACKGROUND', 'citation': 'Mustian KM, Peppone L, Darling TV, Palesh O, Heckler CE, Morrow GR. A 4-week home-based aerobic and resistance exercise program during radiation therapy: a pilot randomized clinical trial. J Support Oncol. 2009 Sep-Oct;7(5):158-67.'}, {'pmid': '20556760', 'type': 'BACKGROUND', 'citation': 'McNeely ML, Campbell K, Ospina M, Rowe BH, Dabbs K, Klassen TP, Mackey J, Courneya K. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD005211. doi: 10.1002/14651858.CD005211.pub2.'}, {'pmid': '20068255', 'type': 'BACKGROUND', 'citation': 'Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.'}, {'pmid': '19675330', 'type': 'BACKGROUND', 'citation': 'Schmitz KH, Ahmed RL, Troxel A, Cheville A, Smith R, Lewis-Grant L, Bryan CJ, Williams-Smith CT, Greene QP. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009 Aug 13;361(7):664-73. doi: 10.1056/NEJMoa0810118.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the acceptability, feasibility and explore the possible effects of an early physical therapy education intervention for breast cancer survivors.', 'detailedDescription': 'This study uses a randomized controlled and longitudinal study design. We will compare two groups - an intervention group and a control group - to test the effects of an early physical therapy education intervention for breast cancer survivors who are candidates for breast cancer surgery. Because of the nature of the intervention (patient early education with 1:1 discussion of educational materials) we will be unable to introduce blinding of the participant as well as the staff.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed with unilateral breast cancer\n* Candidate for breast cancer surgery as first line of cancer treatment\n* Undergo breast cancer surgery at Brigham and Woman's Hospital, Boston, Massachusetts\n* Female\n* English speaking\n* Greater than or equal to 21 years old\n\nExclusion Criteria:\n\n* Previous history of breast cancer and/or recurrent/metastatic disease\n* Receiving neoadjuvant chemotherapy treatment\n* Bilateral breast cancer\n* History of shoulder impairments or severe upper quarter scarring\n* Pregnancy\n* Central nervous system damage\n* Dementia\n* History of other previous cancers (except non-melanoma skin)\n* Systemic medical conditions (e.g.: fibromyalgia, rheumatoid arthritis, etc.)\n* Amputation of either upper extremity"}, 'identificationModule': {'nctId': 'NCT04731805', 'briefTitle': 'Moving On - An RCT to Test Physical Therapy Education', 'organization': {'class': 'OTHER', 'fullName': 'Northeastern University'}, 'officialTitle': '"Moving On" - A Randomized Controlled Trial for Acceptability and Feasibility of an Early Physical Therapy Education Intervention for Breast Cancer Surgical Candidates', 'orgStudyIdInfo': {'id': '12-04-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moving On After Breast Cancer - Intervention Arm', 'description': 'Participants are randomized to the intervention arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Participants are given the patient education materials (booklet, therapeutic exercise DVD, small ball, range of motion wand). The research assistant orients the participant to the education materials and summarizes each section of the booklet. The research assistant also teaches the participant how to do the therapeutic exercises in the booklet. All participants in the intervention also receive usual care.', 'interventionNames': ['Behavioral: Moving On After Breast Cancer']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants are randomized to the usual care arm after their breast cancer diagnosis (but before cancer surgery) and baseline measurements (T0) are taken. They are followed up again at 2 weeks after their breast cancer surgery (T1), and again at 3 months after surgery (T2). Usual care consists of pre-operative testing, pre-operative nursing education on care of the surgical incision and pain management followed by breast cancer surgery.'}], 'interventions': [{'name': 'Moving On After Breast Cancer', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention arm'], 'description': 'Patient education intervention that is evidence-based, physical therapy, patient \\& family centered through the use of face to face instruction, a booklet, and therapeutic exercise DVD. The education materials are designed to deliver information on short term, long term, and late physical and functional effects of breast cancer treatment and given to breast cancer survivors before beginning cancer treatment. The education materials are designed to be used before, during, and after breast cancer treatment.', 'armGroupLabels': ['Moving On After Breast Cancer - Intervention Arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ann M Flores, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeastern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeastern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Physical Therapy Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ann Marie Flores', 'investigatorAffiliation': 'Northeastern University'}}}}