Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-01-01
2018-07-30
Brief Summary
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Detailed Description
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Objective: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention exercise
The experimental group received education and exercise training before a mastectomy.
education
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.
Control
Received routine hospital care which did not include any exercise education
No interventions assigned to this group
Interventions
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education
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed with breast cancer
* scheduled for modified radical mastectomy. .
Exclusion Criteria
* not able to communicate,
* had co-morbidities that affected their QoL
33 Years
55 Years
FEMALE
No
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Principal Investigators
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Iman Kouatly, MpH
Role: STUDY_DIRECTOR
American University of Beirut Medical Center
Locations
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American University Medical Center (AUBMC)
Beirut, , Lebanon
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NU04
Identifier Type: -
Identifier Source: org_study_id
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