Effectiveness of Self-Physiotherapy in the Management of Lymphedema

Trial Title: Effectiveness of Self-Physiotherapy in the Management of Lymphedema

NCT ID: NCT06652295

Condition: Breast Cancer
Lymphedema
Self Care
Quality of Healthcare
Self Management

Conditions: Official terms:
Breast Neoplasms
Lymphedema

Conditions: Keywords:
Breast cancer
Upper extremity lymphedema
Complex Decongestive Physiotherapy
Self Management
Health-Related Quality of Life

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: An independent assessor who is unaware of the group of participants going to perform all evaluations.

Intervention:

Intervention type: Other
Intervention name: Complex decongestive physiotherapy (CDP)
Description: 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.
Arm group label: Intervention/Treatment

Intervention type: Other
Intervention name: Self-administered Complex Decongestive Physiotherapy (CDP)
Description: 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.
Arm group label: Self-administered Group

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 34 BCRL patients, 17 in the standard treatment (CDP administered by a physiotherapist) group and 17 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. All participants were called one month after the end of treatment to assess short-term outcomes. Participants will be recalled after 3 months for the evaluation of long-term results.

Criteria for eligibility:
Criteria:
- Being 18 years of age or older - Having stage 1-3 lymphedema according to the International Society of Lymphology (ISL) classification - Having a diagnosis of unilateral breast cancer-related lymphedema (Doppler, lymphoscintigraphy, and computed tomography were preferred to confirm the diagnosis of lymphedema based on a comprehensive medical assessment and condition of the patient) - No evidence/suspicion of cancer recurrence after completion of adjuvant local and systemic therapies for at least 12 months - Not having received a complex decongestive physiotherapy programme in the last 6 months - Volunteer to participate in the study Able to read and understand Turkish. 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).

Gender: Female

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Dokuz Eylul University

Address:
City: Izmir
Zip: 35210
Country: Turkey

Start date: January 1, 2024

Completion date: January 25, 2025

Lead sponsor:
Agency: Dokuz Eylul University
Agency class: Other

Source: Dokuz Eylul University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06652295