Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema

During the Covid-19 pandemic, rehabilitation services for all patients were affected, and a term that was previously in use but gained popularity during the pandemic entered our vocabulary: 'Telerehabilitation'. The purpose of our study is to evaluate the treatment process and adherence of patients undergoing telerehabilitation.

Study Overview

• Status: Completed
• Conditions: Telerehabilitation; Breast Cancer Related Lymphedema
• Intervention / Treatment: Other: Manuel Lymphatic Drainage(MLD), Exercises

Detailed Description

Our study is a randomized single-blind prospective study. Patients aged 18 to 75 years with stage 1-2 lymphedema associated with breast cancer and upper extremity lymphedema, who had undergone breast surgery at least 3 months prior, were included in the study. Group 1: Patients were given a brochure explaining the massage and exercises they should perform. They were periodically contacted by a physiotherapist and clinician to remind them of their tasks. Group 2: Patients underwent telerehabilitation exercises and massages three times a week guided by a physiotherapist and clinician, and on the remaining days, they continued their self-administered tasks. Patients were evaluated three times: before treatment, at weeks 5 and 8 after treatment. During each visit, patients' inter-limb volume difference, Quick DASH and Life Impact Scale scores, pain, tension, stiffness, and heaviness sensations were assessed.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
  • İstanbul, Turkey, 34899
    • Canan Şanal-Toprak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients who had undergone breast surgery at least 3 months ago
• Had stage 1-2 lymphedema
• Had upper extremity lymphedema associated with breast cancer

Exclusion Criteria:

• Signs of infection such as lymphangitis, cellulitis, fungal infections
• Those with documented lymph node metastases
• Those with bilateral lymphedema
• Those with other diseases affecting upper extremity functions
• Those with a history of previous surgery related to the upper extremity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Group; patients received exercises and massages through TR three times a week, conducted by a physiotherapist and a clinician. They were encouraged to perform their exercises and wear compression garments on the remaining days. Prior to the program, patients or their relatives received training from physiotherapists regarding exercises and Manual Lymphatic Drainage (MLD). Patients or their relatives were informed about the Zoom program and were instructed to acquire the application online. Two physiotherapists and groups of five patients each were organized based on rehabilitation days and hours, and access to the Zoom link was provided.	Other: Manuel Lymphatic Drainage(MLD), Exercises; MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin. Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure. Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.
Active Comparator: Home- Exercise Group; patients were provided with a brochure explaining the massages and exercises they needed to perform. Additionally, they were contacted three times a week by a physiotherapist and a clinician to remind them of the treatments, assess the continuity and accuracy of the treatments, encourage them to perform the treatments correctly and consistently, and promote the wearing of compression garments.	Other: Manuel Lymphatic Drainage(MLD), Exercises; MLD:It is a unique massage technique that uses specific hand movements to provide a gentle pumping effect on the skin. Massage movements follow the direction of lymph flow and produce rapid results. The aim of this method is to achieve maximum skin tightening effect with minimum pressure. Exercise, on the other hand, increases physical performance, improves body composition, and provides an increase in quality of life by providing acute and chronic reductions in fatigue. Both aerobic exercises and strengthening exercises have been found effective on physical performance. It shows that a mixed program consisting of components such as aerobics, strengthening, coordination and stretching can positively affect flexibility, pain and energy expenditure in breast cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: Day 0
Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: 5 weeks
Volume Measurements	Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3	Time Frame: 8 weeks
Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: Day 0
Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: 5 weeks
Symptom Severity	Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)	Time Frame: 8 weeks
Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: Day 0
Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: 5 weeks
Functionality	Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire	Time Frame: 8 weeks
Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: Day 0
Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: 5 weeks
Efficacity	Lymphedema Quality of Life Impact Scale	Time Frame: 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with the treatment	Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied	Time Frame: 5 weeks
Patient satisfaction with the treatment	Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied	Time Frame: 8 weeks
patients were asked to compare their hand functionality to before the injury	Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse	Time Frame: 5 weeks
patients were asked to compare their hand functionality to before the injury	Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse	Time Frame: 8 weeks

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: CANAN ŞANAL TOPRAK, Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: 09.2021.131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No