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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Cancer Related Lymphedema, Telerehabilitation

Intervention / Treatment
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* Other: Manuel Lymphatic Drainage(MLD), Exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation Group<br>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<br>* 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.<br>|
| Active Comparator: Home- Exercise Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |