Breast Edema Compression Vest

Study Overview
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Brief Summary
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A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies. The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.

Detailed Description
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In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating. Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period. Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).

Official Title
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The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.

Conditions
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Edema, Lymphedema, Breast Neoplasm, Breast Cancer

Intervention / Treatment
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* Device: Compression vest, Thuasne


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females, aged 18 years and older. Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain). Visual Analog Scale (VAS) pain score of 3 or more. Exclusion Criteria: Inability to understand the Dutch language. Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months. Cardiac complaints. Pacemaker. Port-a-cath. Thrombosis of the arm. Pulmonary embolism. Pulmonary disease. Pregnancy. Non-breast cancer related lymph edema. Clinical depression or anxiety disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: breast edema vest<br> | Device: Compression vest, Thuasne<br>* Wearing a compression 4 days/weel with a minumum of 6 hours per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of wearing a compression vest on patient reported outcome pain | Brief Pain Inventory (BPI) for pain questionnaire | At baseline | 
| Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest | Brief Pain Inventory (BPI) for pain questionnaire | 2 weeks | 
| Effect of wearing a compression vest on patient reported outcome pain one month after wearing a compression vest | Brief Pain Inventory (BPI) for pain questionnaire | 1 month | 
| Effect of wearing a compression vest on patient reported outcome pain three months after wearing a compression vest | Brief Pain Inventory (BPI) for pain questionnaire | 3 months | 
| Effect of wearing a compression vest on patient reported outcome pain six months after wearing a compression vest | Brief Pain Inventory (BPI) for pain questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of wearing a compression vest on degree of breast edema (CTCAE score) | During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered. | At baseline | 
| Effect of wearing a compression vest on degree of breast edema (CTCAE score) | During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered. | At 1 month | 
| Effect of wearing a compression vest on degree of breast edema (CTCAE score) | During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered. | At 3 months | 
| Effect of wearing a compression vest on degree of breast edema (CTCAE score) | During each study related visit to the hospital CTCAE score (Common Terminology Criteria for Adverse Events version 4.0) will be registered. | At 6 months | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-C30 for quality of life and breast edema symptoms | At baseline | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-C30 for quality of life and breast edema symptoms | At 2 weeks after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-C30 for quality of life and breast edema symptoms | At 1 month after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-C30 for quality of life and breast edema symptoms | At 3 months after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-C30 for quality of life and breast edema symptoms | At 6 months after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-BR23 for quality of life and breast edema symptoms | At baseline | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-BR23 for quality of life and breast edema symptoms | At 2 weeks after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-BR23 for quality of life and breast edema symptoms | At 1 month after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-BR23 for quality of life and breast edema symptoms | At 3 months after wearing a compression vest | 
| Effect of wearing a compression vest on patient reported quality of life | EORTC QLQ-BR23 for quality of life and breast edema symptoms | At 6 months after wearing a compression vest |