This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema
The overall range of compression devices dedicated to lymphedema treatment offers standard or custom-made garments and different types of bandages. Indeed, bandages are not easy to put on, requiring specific patient's skills and/or assistance which is not optimal for long-term compliance. Moreover, they are composed of several layers forming a quite bulky multilayer bandage that limits limb function and does not contribute to a better quality of life. For all these reasons described, even if bandaging is the current reference of lymphedema treatment, they have disadvantages. The day-time elastic compressive armsleeves are proposed as an alternative to bandages. However, whatever their standard or custom-made design, they cannot adapt to limb volume/morphology evolution on the long-term management of this chronic disease because they are not adjustable. Therefore, as the comfort of treatment is very important in improving compliance, armsleeves are sometimes poorly tolerated by patients resulting in decreasing compliance to treatment plan. In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks
In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks. During the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks
ANKARA
Ankara, Turkey (Türkiye)
RECRUITINGPinar BORMAN
Ankara, Turkey (Türkiye)
RECRUITINGVolume excess variation
The primary endpoint of this study is to compare between both groups the volume evolution of the upper limb between inclusion and the end of the study. Limb Volume is calculated with truncated cone formula.
Time frame: 8 weeks
Resource consumption
Resource consumption is measured by time of transports (travel time in minutes).
Time frame: 3 and 8 weeks
Resource consumption
Resource consumption is measured by number of used medical devices (number).
Time frame: 3 and 8 weeks
Resource consumption
Resource consumption is measured by the number and duration (per minute) of lymphedema-related healthcare consultations and hospitalizations.
Time frame: 3 and 8 weeks
Lymphedema related Quality of life (QoL)
The evolution of QoL is measured by LYMQOL ARM self-questionnaire and specific questions. This tool is designed as patient-completed questionnaire. The questions cover four domains : symptoms, body image/appearance, function, mood. Each item in each domain is scored : not at all (1), a little (2), Quite a bit (3), A lot (4). Specific questions are about patient's perception of benefit
Time frame: 3 and 8 weeks
Doctors' opinion on improving the patient's health condition
Doctors' opinion on improving the patient's health condition caused by lymphedema is measured by the CGI-I questionnaire (Clinical Global Improvement Impression). This questionnaire allows doctors to evaluate the improvement of patients. The scale has 7 levels from "very strongly improved"(better outcome) to "very strongly aggravated"(worse outcome).Intermediate levels are: " Significantly improved " ; " Slightly improved " ; " No improvement " ; " Slightly aggravated " ; " Seriously aggravated "
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Time frame: 3 and 8 weeks
Patient's opinion on Global Impression of Change
Patient's opinion on Global Impression of Change about her general condition is measured by the PGI-C questionnaire (Patient's opinion on Global Impression of Change). The scale has 7 levels from "no change or condition has got worsed"(worse outcome) to "a great deal better, and a considerable improvement that has made all the difference ( better outcome)". Intermediate levels are: "almost the same, hardly any change at all"; "a little better, but no noticeable change", "somewhat better, but the change has not made any real difference"; "moderately better, and a slight but noticeable change"; "better, and a definite improvement that has made a real and worthwhile difference
Time frame: 3 and 8 weeks
Satisfaction about the device
Patient's satisfaction with regards to MOBIDERM® Autofit vs bandages is measured by a satisfaction questionnaire. This questionnaire is focused on the product positioning with a question with 4 levels: very easy (better outcome), easy, difficult, very difficult (worse outcome) and the comfort with a question with 4 levels very comfortable (better outcome), comfortable, uncomfortable, very uncomfortable (worse outcome).
Time frame: 8 weeks
The safety
Number and type of serious and non-serious Adverse Device Effects (ADE).
Time frame: 8 weeks
Compliance to treatment
The compliance to treatment (day-time and night-time) is reported by the physician in the e-CRF according to the patient diary. The compliance is measured in number of days and or nights when the device is worn and the average wearing time
Time frame: 8 weeks
General quality of life (QoL)
The evolution of QoL is measured by the EQ5D3L questionnaire completed by the patient. The EQ-5D3L questionnaire has two components: health state description and evaluation. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems (Level 1 is coded as a '1'), moderate problems (Level 2 is coded as a '2'), and extreme problems (Level 3 is coded as a '3'). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS). The EQ VAS is measured by VAS : 100 corresponds to the best health and 0 to the the worst health.
Time frame: 3 and 8 weeks
Skin elasticity
The evolution of skin thickness and elasticity is measured by ultrasound
Time frame: 3 and 8 weeks
Ttissue induration
The evolution of tissue induration is measured via the skinfibrometer (Delfin Tech).
Time frame: 3 and 8 weeks