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.Exercise and Follow-up After a Mastectomy (mastectomy)

Primary Purpose

Mastectomy; Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
education
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mastectomy; Lymphedema focused on measuring mastectomy, education, exercise

Eligibility Criteria

33 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria included:

  • women between 35 and 55 years of age
  • diagnosed with breast cancer
  • scheduled for modified radical mastectomy. .

Exclusion Criteria included:

  • Women who were pregnant,
  • not able to communicate,
  • had co-morbidities that affected their QoL

Sites / Locations

  • American University Medical Center (AUBMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention exercise

Control

Arm Description

The experimental group received education and exercise training before a mastectomy.

Received routine hospital care which did not include any exercise education

Outcomes

Primary Outcome Measures

Measuring the range of motion of the affected shoulder at two weeks.
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.
Measuring the range of motion of the affected shoulder at four weeks.
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.
Assessing the quality of life of participants at two weeks
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.
Assessing the Quality of life of participants at four weeks
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
December 2, 2019
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04184102
Brief Title
.Exercise and Follow-up After a Mastectomy
Acronym
mastectomy
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy; Lymphedema
Keywords
mastectomy, education, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to a control of experimental group by flipping a coin
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention exercise
Arm Type
Experimental
Arm Description
The experimental group received education and exercise training before a mastectomy.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Received routine hospital care which did not include any exercise education
Intervention Type
Behavioral
Intervention Name(s)
education
Other Intervention Name(s)
Exercise Modeling
Intervention 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.
Primary Outcome Measure Information:
Title
Measuring the range of motion of the affected shoulder at two weeks.
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.
Time Frame
At 2 weeks after surgery
Title
Measuring the range of motion of the affected shoulder at four weeks.
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.
Time Frame
At 4 weeks after surgery
Title
Assessing the quality of life of participants at two weeks
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.
Time Frame
At two weeks after surgery
Title
Assessing the Quality of life of participants at four weeks
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.
Time Frame
At 4 weeks after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women diagnosed with breast cancer women undergoing a modified radical mastectomy
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria included: women between 35 and 55 years of age diagnosed with breast cancer scheduled for modified radical mastectomy. . Exclusion Criteria included: Women who were pregnant, not able to communicate, had co-morbidities that affected their QoL
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman Kouatly, MpH
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
American University Medical Center (AUBMC)
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21344265
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.
Results Reference
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PubMed Identifier
21224783
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.
Results Reference
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PubMed Identifier
24382677
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.
Results Reference
background
PubMed Identifier
28331674
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.
Results Reference
background
PubMed Identifier
23033300
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.
Results Reference
background
PubMed Identifier
25555831
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.
Results Reference
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PubMed Identifier
20556760
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.
Results Reference
background
PubMed Identifier
31465139
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.
Results Reference
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PubMed Identifier
33219500
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.
Results Reference
derived

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.Exercise and Follow-up After a Mastectomy

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