Effectiveness of Self-Physiotherapy in the Management of Lymphedema

NCT ID: NCT06652295

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-25

Brief Summary

Breast cancer-related lymphedema is a chronic condition adversely affecting physical, social, psychological and emotional well-being. The complex decongestive physiotherapy (CDP) programme is considered the gold standard in the management of lymphedema. The most important barriers affecting patient participation in the CDP programme are the lack of trained health personnel and the difficulty for patients to access treatment (peripheral location or financial difficulties). Therefore, self-administration of the CDP programme may contribute to the development of self-care strategies and the reduction of treatment costs.

Detailed Description

Breast cancer (BC) is the most common type of cancer in women according to the GLOBOCAN cancer data. The advancements in BC screening, diagnosis and treatment have increased the 5-year survival rate to more than 90%. On the other hand, the chronic disease process and side effects of treatment in BC survivors have been reported to lead to significant morbidities. Breast cancer-related lymphedema (BCRL) is reported as one of the most common morbidities leading to impaired upper extremity functionality and decreased quality of life. Lymphedema is a chronic condition characterized by abnormal accumulation of protein-rich fluid in the interstitial space due to insufficient lymphatic drainage. Complex decongestive physiotherapy (CDP) (patient education, manual lymph drainage, compression, exercise, skin care) programme is considered the gold standard modality in the management of lymphedema. On the other hand, the CDP programme is time-consuming, the high cost of health expenditures and the insufficient number of health personnel with expertise in the field are the major barriers for BCRL patients to participate in the CDP programme. Additionally, some of the patients have difficulties in reaching the treatment due to their peripheral locations. Moreover, considering the chronic nature of lymphedema, patients usually require several CDP application for the management of lymphedema throughout their life. Therefore, the development of self-management programme which are transferable across regional and economic boundaries might emerge as an important approach to reduce healthcare costs and improve long-term outcomes in lymphedema management. Most studies of self-management in lymphedema focus on patient education and for using compression garments. On the other hand, recent findings have suggested the most effective approach to lymphedema management is to incorporate all components of the CDP programme as a multimodal approach. Therefore, this study aims to investigate the feasibility of the CDP protocol as a self-management treatment option by BCRL patients. Self-administered CDP protocol may be a practice that enables the patient to adopt self-care activities, reducing treatment costs and physiotherapist workload. The primary aim of the study was to compare the effectiveness of self-management and physiotherapist-administered CDP on lymphedema severity in patients with BCRL. The secondary aim was to compare the efficacy of self-management and physiotherapist-administered CDP on disease-related clinical outcomes in patients with BCRL.

The study is a single-blind randomized controlled study with pre-test post-test design. The study consisted of a total of 50 BCRL patients, 25 in the standard treatment (CDP administered by a physiotherapist) group and 25 in the self-administered CPD group.

Participants were randomly assigned to one of two possible experimental conditions: (1) a physiotherapist-administered CDP programme or (2) a self-administered CDP programme. The CDP programme consisted of patient education, manual lymph drainage, short traction bandaging and remedial exercises. Before the CDP programme, the participants were provided one session of patient education and the patients were informed about all applications. Each component of the self-CDP programme was presented to the participants with a lymphedema patient booklet and a video prepared by the researchers. Both experimental groups enrolled in the study for five days a week for three weeks. Patients in the Self-CDP group was followed up once a week with a patient follow-up diary. A blinded physiotherapist performed all pre- and post-treatment assessments. Breast cancer (BC) is the most common type of cancer in women according to the GLOBOCAN cancer data. The advancements in BC screening, diagnosis and treatment have increased the 5-year survival rate to more than 90%. On the other hand, the chronic disease process and side effects of treatment in BC survivors have been reported to lead to significant morbidities. Breast cancer-related lymphedema (BCRL) is reported as one of the most common morbidities leading to impaired upper extremity functionality and decreased quality of life. Lymphedema is a chronic condition characterized by abnormal accumulation of protein-rich fluid in the interstitial space due to insufficient lymphatic drainage. Complex decongestive physiotherapy (CDP) (patient education, manual lymph drainage, compression, exercise, skin care) programme is considered the gold standard modality in the management of lymphedema. On the other hand, the CDP programme is time-consuming, the high cost of health expenditures and the insufficient number of health personnel with expertise in the field are the major barriers for BCRL patients to participate in the CDP programme. Additionally, some of the patients have difficulties in reaching the treatment due to their peripheral locations. Moreover, considering the chronic nature of lymphedema, patients usually require several CDP application for the management of lymphedema throughout their life. Therefore, the development of self-management programme which are transferable across regional and economic boundaries might emerge as an important approach to reduce healthcare costs and improve long-term outcomes in lymphedema management. Most studies of self-management in lymphedema focus on patient education and for using compression garments. On the other hand, recent findings have suggested the most effective approach to lymphedema management is to incorporate all components of the CDP programme as a multimodal approach. Therefore, this study aims to investigate the feasibility of the CDP protocol as a self-management treatment option by BCRL patients. Self-administered CDP protocol may be a practice that enables the patient to adopt self-care activities, reducing treatment costs and physiotherapist workload. The primary aim of the study was to compare the effectiveness of self-management and physiotherapist-administered CDP on lymphedema severity in patients with BCRL. The secondary aim was to compare the efficacy of self-management and physiotherapist-administered CDP on disease-related clinical outcomes in patients with BCRL.

The study is a single-blind randomized controlled study with pre-test post-test design. The study consisted of a total of 50 BCRL patients, 25 in the standard treatment (CDP administered by a physiotherapist) group and 25 in the self-administered CPD group.

Participants were randomly assigned to one of two possible experimental conditions: (1) a physiotherapist-administered CDP programme or (2) a self-administered CDP programme. The CDP programme consisted of patient education, manual lymph drainage, short traction bandaging and remedial exercises. Before the CDP programme, the participants were provided one session of patient education and the patients were informed about all applications. Each component of the self-CDP programme was presented to the participants with a lymphedema patient booklet and a video prepared by the researchers. Both experimental groups enrolled in the study for five days a week for three weeks. Patients in the Self-CDP group was followed up once a week with a patient follow-up diary. A blinded physiotherapist performed all pre- and post-treatment assessments.Participants will be recalled after 3 months for re-assessment of lymphoedema severity and symptoms.

Conditions

Breast Cancer; Lymphedema; Self Care; Quality of Healthcare; Self Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention/Treatment

This group was enrolled in a complex decongestive physiotherapy programme administered by a physiotherapist five days a week for three weeks.

Group Type: ACTIVE_COMPARATOR

Complex decongestive physiotherapy (CDP)

Intervention Type: OTHER

CDP consists of patient education, manual lymph drainage, short traction bandaging, skin/nail care and exercise. The applications of all modalities of the CDP programme were performed by the physiotherapist.

Self-administered Group

This group was enrolled in a self-administered complex decongestive physiotherapy programme five days a week for three weeks.

Group Type: OTHER

Self-administered Complex Decongestive Physiotherapy (CDP)

Intervention Type: OTHER

The self-administered CDP programme consisted of patient education, self-manual lymph drainage, self-short traction bandage application, self-skin/nail care and exercise. Participants were given one session of patient education before the self-administered CDP programme and patients were given practical information about all applications. Additionally, each component of the self-administered CDP programme was presented to the participants with a patient booklet and a video prepared by the researchers. Patients in the self-CDP group were followed up once a week with a patient follow-up diary.

Interventions

Complex decongestive physiotherapy (CDP)

CDP consists of patient education, manual lymph drainage, short traction bandaging, skin/nail care and exercise. The applications of all modalities of the CDP programme were performed by the physiotherapist.

Intervention Type: OTHER

Self-administered Complex Decongestive Physiotherapy (CDP)

The self-administered CDP programme consisted of patient education, self-manual lymph drainage, self-short traction bandage application, self-skin/nail care and exercise. Participants were given one session of patient education before the self-administered CDP programme and patients were given practical information about all applications. Additionally, each component of the self-administered CDP programme was presented to the participants with a patient booklet and a video prepared by the researchers. Patients in the self-CDP group were followed up once a week with a patient follow-up diary.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Inability to understand the questionnaires and refusal to participate
• History of congenital lymphedema or bilateral upper extremity lymphedema or malignant lymphedema
• Presence of neurological or mental illness or axillary web syndrome, major organ failure, or/ iatrogenic disease that may adversely affect the severity of lymphedema (such as using steroids, nonsteroidal anti-inflammatory drugs, and calcium channel blockers)
• Presence of conditions contraindicated for complex decongestive physiotherapy (active infection, deep vein thrombosis/thrombophlebitis, cardiac oedema, pulmonary disease, peripheral arterial disease, any skin disease such as scleroderma, allergic reactions to treatment).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Sukriye Cansu Gultekin

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DEU-FTR-SCG-01

Identifier Type: -

Identifier Source: org_study_id