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

Not Applicable

Completed

• Conditions: Telerehabilitation; Breast Cancer Related Lymphedema
• Interventions: Other: Manuel Lymphatic Drainage(MLD), Exercises

• Registration Number: NCT06065423
• Lead Sponsor: Marmara University

Brief Summary

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

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 Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2023-06-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation Group	Manuel Lymphatic Drainage(MLD), Exercises	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.
Home- Exercise Group	Manuel Lymphatic Drainage(MLD), Exercises	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Canan Şanal-Toprak; 🇹🇷 İstanbul, Turkey

Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey