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

Primary Purpose

Breast Cancer Related Lymphedema, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manuel Lymphatic Drainage(MLD), Exercises
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Related Lymphedema

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation Group

Home- Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient satisfaction with the treatment
Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied
Patient satisfaction with the treatment
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
Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse
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

Full Information

First Posted
September 26, 2023
Last Updated
September 26, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT06065423
Brief Title
Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
Official Title
Evaluation of Home Program and Telerehabilitation for the Treatment Process in Patients With Breast Cancer-Related Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Related Lymphedema, Telerehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Home- Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manuel Lymphatic Drainage(MLD), Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume Measurements
Description
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Time Frame
Time Frame: Day 0
Title
Volume Measurements
Description
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Time Frame
Time Frame: 5 weeks
Title
Volume Measurements
Description
Arm measurement was measured with a tape measure at 4 cm intervals and calculated using the cone method in cm3
Time Frame
Time Frame: 8 weeks
Title
Symptom Severity
Description
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Time Frame
Time Frame: Day 0
Title
Symptom Severity
Description
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Time Frame
Time Frame: 5 weeks
Title
Symptom Severity
Description
Shoulder pain, tightness, sensation of heaviness, and stiffness were evaluated using a numerical scale (1 to 10 points)
Time Frame
Time Frame: 8 weeks
Title
Functionality
Description
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Time Frame
Time Frame: Day 0
Title
Functionality
Description
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Time Frame
Time Frame: 5 weeks
Title
Functionality
Description
Ouick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire
Time Frame
Time Frame: 8 weeks
Title
Efficacity
Description
Lymphedema Quality of Life Impact Scale
Time Frame
Time Frame: Day 0
Title
Efficacity
Description
Lymphedema Quality of Life Impact Scale
Time Frame
Time Frame: 5 weeks
Title
Efficacity
Description
Lymphedema Quality of Life Impact Scale
Time Frame
Time Frame: 8 weeks
Secondary Outcome Measure Information:
Title
Patient satisfaction with the treatment
Description
Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied
Time Frame
Time Frame: 5 weeks
Title
Patient satisfaction with the treatment
Description
Responses were gathered on a scale of very satisfied - satisfied - somewhat satisfied - unsatisfied
Time Frame
Time Frame: 8 weeks
Title
patients were asked to compare their hand functionality to before the injury
Description
Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse
Time Frame
Time Frame: 5 weeks
Title
patients were asked to compare their hand functionality to before the injury
Description
Responses were gathered on a scale of 'much better - somewhat better - same - somewhat worse - much worse
Time Frame
Time Frame: 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CANAN ŞANAL TOPRAK
Organizational Affiliation
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Canan Şanal-Toprak
City
İstanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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