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

• 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

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