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

NCT06065423 | Completed

• 1 other identifier: 09.2021.131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer Related Lymphedema; Telerehabilitation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Patient satisfaction with the treatment

  Time Frame: 5 weeks

• Patient satisfaction with the treatment

  Time Frame: 8 weeks

• patients were asked to compare their hand functionality to before the injury

  Time Frame: 5 weeks

• patients were asked to compare their hand functionality to before the injury

  Time Frame: 8 weeks

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

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

Home- Exercise Group

ACTIVE COMPARATOR

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

Interventions

Manuel Lymphatic Drainage(MLD), Exercises OTHER

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.

Home- Exercise Group; Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Canan Şanal-Toprak

Istanbul, 34899, Turkey (Türkiye)

Location

Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• CANAN ŞANAL TOPRAK

  Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation

  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

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)