Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04184102
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2019-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
.Exercise and Follow-up After a Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-30', 'size': 428694, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-28T02:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to a control of experimental group by flipping a coin'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-02', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the range of motion of the affected shoulder at two weeks.', 'timeFrame': 'At 2 weeks after surgery', 'description': 'Measurement of shoulder range of motion using a Goniometer at two time points. The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy. The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint. Normal values are abduction: 150 degrees. adduction: 30 degrees, orward flexion: 150-180 degrees, Extension: 45-60 degrees and rotation (test with elbow flexed to 90 degrees). The "Goniometer" is a nonintrusive and the most commonly used method to assess the ROM of a joint due to its simplicity and ease to implement The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy.The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint.'}, {'measure': 'Measuring the range of motion of the affected shoulder at four weeks.', 'timeFrame': 'At 4 weeks after surgery', 'description': 'Measurement of shoulder range of motion using a Goniometer at two time points. The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy. The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint. Normal values are abduction: 150 degrees. adduction: 30 degrees, orward flexion: 150-180 degrees, Extension: 45-60 degrees and rotation (test with elbow flexed to 90 degrees). The "Goniometer" is a nonintrusive and the most commonly used method to assess the ROM of a joint due to its simplicity and ease to implement The goniometer is a reliable tool which has been used in several studies to assess ROM of the of affected shoulder in patients after mastectomy.The goniometer assesses the range of motion, flexion, unbending, abduction, external rotation, and inward rotation of the shoulder joint.'}, {'measure': 'Assessing the quality of life of participants at two weeks', 'timeFrame': 'At two weeks after surgery', 'description': 'Qaulity of lfe was assessed at points in time. The Quality of Life Instrument: The Breast Cancer Patient Version (QoL-BC) was used to asses QoL. The QoL-BC is a patient self-reported scale assessing concerns of cancer survivors.It includes 46 items assessing four domains: 1) physical well-being (8 items), 2) psychological well-being, (22 items), 3) social well-being,(9 items) and 4) spiritual well-being (7 items). The itmes are scored form 0 to 10, 0 = worst outcome to 10 = best outcome. Several items have reverse anchors and therefore when you code the items you will need to reverse the scores of those items. Higher scores indicate better outocme.The overall and the subscales instrument have shown excellent internal and external reliability and moderate to strong validity.The QoL-BC has been translated to Arabic and used with breast cancer patients in several Arab countries with good reliability and validity.'}, {'measure': 'Assessing the Quality of life of participants at four weeks', 'timeFrame': 'At 4 weeks after surgery', 'description': 'Qaulity of lfe was assessed at points in time. The Quality of Life Instrument: The Breast Cancer Patient Version (QoL-BC) was used to asses QoL. The QoL-BC is a patient self-reported scale assessing concerns of cancer survivors.It includes 46 items assessing four domains: 1) physical well-being (8 items), 2) psychological well-being, (22 items), 3) social well-being,(9 items) and 4) spiritual well-being (7 items). The itmes are scored form 0 to 10, 0 = worst outcome to 10 = best outcome. Several items have reverse anchors and therefore when you code the items you will need to reverse the scores of those items. Higher scores indicate better outocme.The overall and the subscales instrument have shown excellent internal and external reliability and moderate to strong validity.The QoL-BC has been translated to Arabic and used with breast cancer patients in several Arab countries with good reliability and validity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mastectomy', 'education', 'exercise'], 'conditions': ['Mastectomy; Lymphedema']}, 'referencesModule': {'references': [{'pmid': '21344265', 'type': 'BACKGROUND', 'citation': 'Garlick M, Wall K, Corwin D, Koopman C. Psycho-spiritual integrative therapy for women with primary breast cancer. J Clin Psychol Med Settings. 2011 Mar;18(1):78-90. doi: 10.1007/s10880-011-9224-9.'}, {'pmid': '21224783', 'type': 'BACKGROUND', 'citation': 'Eyigor S, Karapolat H, Yesil H, Uslu R, Durmaz B. Effects of pilates exercises on functional capacity, flexibility, fatigue, depression and quality of life in female breast cancer patients: a randomized controlled study. Eur J Phys Rehabil Med. 2010 Dec;46(4):481-7.'}, {'pmid': '24382677', 'type': 'BACKGROUND', 'citation': 'Brandstatter M, Kogler M, Baumann U, Fensterer V, Kuchenhoff H, Borasio GD, Fegg MJ. Experience of meaning in life in bereaved informal caregivers of palliative care patients. Support Care Cancer. 2014 May;22(5):1391-9. doi: 10.1007/s00520-013-2099-6. Epub 2014 Jan 3.'}, {'pmid': '28331674', 'type': 'BACKGROUND', 'citation': 'Yildiz I, Varol U, Alacacioglu A. Assessment of the Quality of Life in Turkish Breast Cancer Patients. J Breast Health. 2014 Oct 1;10(4):216-221. doi: 10.5152/tjbh.2014.2012. eCollection 2014 Oct.'}, {'pmid': '23033300', 'type': 'BACKGROUND', 'citation': 'Sisman H, Sahin B, Duman BB, Tanriverdi G. Nurse-assisted education and exercise decrease the prevalence and morbidity of lymphedema following breast cancer surgery. J BUON. 2012 Jul-Sep;17(3):565-9.'}, {'pmid': '25555831', 'type': 'BACKGROUND', 'citation': 'Bluethmann SM, Vernon SW, Gabriel KP, Murphy CC, Bartholomew LK. Taking the next step: a systematic review and meta-analysis of physical activity and behavior change interventions in recent post-treatment breast cancer survivors. Breast Cancer Res Treat. 2015 Jan;149(2):331-42. doi: 10.1007/s10549-014-3255-5. Epub 2015 Jan 3.'}, {'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': '31465139', 'type': 'RESULT', 'citation': 'Benton MJ, Schlairet MC, Graham HL. Physical activity-related quality of life in breast cancer survivors compared to healthy women. Eur J Cancer Care (Engl). 2019 Nov;28(6):e13142. doi: 10.1111/ecc.13142. Epub 2019 Aug 29.'}, {'pmid': '33219500', 'type': 'DERIVED', 'citation': 'Majed M, Neimi CA, Youssef SM, Takey KA, Badr LK. The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, an RCT. J Cancer Educ. 2022 Jun;37(3):843-851. doi: 10.1007/s13187-020-01894-z. Epub 2020 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'A Randomized Control Trial (RCT) on the effect of education and Exercise on women after a mastectomy found positive results in range of motion of the affected shoulder and quality of life in the intervention group.', 'detailedDescription': 'Background: Breast cancer ranks highest in incidence and mortality among females and ranks second when both genders are combined. Lebanon has the second highest rate of breast cancer worldwide for the 35-39 age group and the highest in the 40-49 age group. Mastectomy often results in deceased shoulder and arm mobility, and decreased Quality of Life.\n\nObjective: The objective of this study was to assess the effect of an educational program of therapeutic exercises on the quality of life and functional ability in women after a mastectomy Methods: Sixty women undergoing mastectomy were randomly assigned to an intervention and control group. The intervention group received extensive teaching pre-surgery education as well as training on therapeutic exercises. Follow up phone calls to the Intervention group were made to assure that the exercises were being done. Both groups were visited at home at four and eight to obtain the outcome variables. The Breast Cancer Patient Version was used to asses quality of life and the "Goniometer" was used to assess the range of motion of the affected shoulder.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '33 Years', 'genderBased': True, 'genderDescription': '* women diagnosed with breast cancer\n* women undergoing a modified radical mastectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria included:\n\n* women between 35 and 55 years of age\n* diagnosed with breast cancer\n* scheduled for modified radical mastectomy. .\n\nExclusion Criteria included:\n\n* Women who were pregnant,\n* not able to communicate,\n* had co-morbidities that affected their QoL'}, 'identificationModule': {'nctId': 'NCT04184102', 'acronym': 'mastectomy', 'briefTitle': '.Exercise and Follow-up After a Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'The Impact of Therapeutic Exercises on the Quality of Life and Shoulder Range of Motion in Women After a Mastectomy, a Randomized Control Trial (RCT)', 'orgStudyIdInfo': {'id': 'NU04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention exercise', 'description': 'The experimental group received education and exercise training before a mastectomy.', 'interventionNames': ['Behavioral: education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Received routine hospital care which did not include any exercise education'}], 'interventions': [{'name': 'education', 'type': 'BEHAVIORAL', 'otherNames': ['Exercise Modeling'], 'description': 'The intervention group received pre-surgery education and training on therapeutic exercises in addition to the routine hospital care. The educational material was developed by the principal investigator (PI) and included a power point and a booklet with instructions on the exercises as well as information about the surgery and what to expect after the surgery. The educational material was based on previous research and adopted to our population after consultation with a panel of experts including two nurses and three physicians. Eligible women were approached while waiting for their appointment with their surgeon. If they showed interest in participating they signed a consent form. The PI explained the study and what is involved in participating including the weekly phone calls for women in the intervention group. Participants were told that they will visited at home by the PI to assess their ROM and to fill out a questionnaire.', 'armGroupLabels': ['Intervention exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University Medical Center (AUBMC)', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Iman Kouatly, MpH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}