Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652295
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Effectiveness of Self-Physiotherapy in the Management of Lymphedema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Self-Physiotherapy in the Management of Lymphedema Following Breast Cancer Treatment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None