Clinical trial NCT06652295: Effectiveness of Self-Physiotherapy in the Management of Lymphedema
Official title: The Effectiveness of Self-Physiotherapy in the Management of Lymphedema Following Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer
Lymphedema
Self Care
Quality of Healthcare
Self Management
Keywords: Breast cancer
Upper extremity lymphedema
Complex Decongestive Physiotherapy
Self Management
Health-Related Quality of Life
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Edema severity
timeFrame: Change from oedema severity baseline at 3 weeks (end of treatment) to 3 months (follow-up sessions)
measure: Symptom Assessment
timeFrame: Change from baseline symptoms at 3 weeks (end of treatment) to 1 month and 3 months (follow-up sessions)
Secondary outcomes:
measure: Range of Motion
timeFrame: Change from baseline upper extremity range of motion at 3 weeks (end of treatment)
measure: Hand grip strength
timeFrame: Change from baseline hand grip strength at 3 weeks (end of treatment)
measure: Assessment of Physical Activity Level
timeFrame: Change from baseline physical activity level at 3 weeks (end of treatment)
measure: Patient Benefit Index
timeFrame: Change from baseline patient benefit index score at 3 weeks (end of treatment)
measure: Health Related Quality of Life Assesment
timeFrame: Change from baseline symptoms at 3 weeks (end of treatment)
measure: Upper Extremity Disability Level
timeFrame: Change from baseline upper extremity disability level at 3 weeks (end of treatment)
measure: Fatigue
timeFrame: Change from baseline symptoms at 3 weeks (end of treatment)
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References: