.Exercise and Follow-up After a Mastectomy

NCT04184102 | Completed DMC

• 1 other identifier: NU04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Lymphedema

Keywords

mastectomy; education; exercise

Outcome Measures

Primary Outcomes (4)

• 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.

  At 2 weeks after surgery

• 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.

  At 4 weeks after surgery

• 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.

  At two weeks after surgery

• 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.

  At 4 weeks after surgery

Study Arms (2)

Intervention exercise

EXPERIMENTAL

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

Behavioral: education

Control

NO INTERVENTION

Received routine hospital care which did not include any exercise education

Interventions

education BEHAVIORAL

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.

Also known as: Exercise Modeling

Intervention exercise

Eligibility Criteria

• Age: 33 Years - 55 Years
• Gender Eligibility Details: * women diagnosed with breast cancer * women undergoing a modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University Medical Center (AUBMC)

Beirut, Lebanon

Location

Related Publications (9)

• 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: 21344265 BACKGROUND

• 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: 21224783 BACKGROUND

• 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: 24382677 BACKGROUND

• 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: 28331674 BACKGROUND

• 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: 23033300 BACKGROUND

• 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: 25555831 BACKGROUND

• 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: 20556760 BACKGROUND

• 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: 31465139 RESULT

• 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.

  PMID: 33219500 DERIVED

MeSH Terms

Conditions

Lymphedema; Motor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Iman Kouatly, MpH

  American University of Beirut Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomly assigned to a control of experimental group by flipping a coin

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: December 3, 2019
• Study Start: January 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: July 30, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)