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User experience with new, aesthetically improved transducer arrays for administration of tumor treating fields for glioblastoma multiforme.

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User experience with new, aesthetically improved transducer arrays for administration of tumor treating fields for glioblastoma multiforme

Laura Benson1, RN, MS, ANP, Adrian Kinzel2, MD, Kimberly Prabhu1, Melissa Shackelford3, and Eilon Kirson4 MD, PhD

1Novocure Inc., New York, NY, USA; 2Novocure GmbH, Munich, Germany; 3Novocure Inc., Portsmouth, NH, USA 4Novocure Ltd., Haifa, Israel
Introduction
Purpose
Tumor Treating Fields (TTFields) are low-intensity, intermediate frequency alternating electric
fields with anti-mitotic activity that are approved for the treatment of adults with newly
diagnosed and recurrent supratentorial glioblastoma multiforme (GBM). TTFields are
administered using the portable home-use Optune® system (Figure 1A and 1B), which is
comprised of two main components – a preset electric field generator and the insulated
transducer arrays (TAs). The current TAs provided to patients consist of 2 opposing pairs of TAs
having ceramic disks (transducers) arranged within a white adhesive bandage designed to hold
the TAs tightly to the shaved scalp (Figure 1C) at carefully predefined locations, based on
individual patients’ MRI data to optimize TTFields delivery to the tumor. In response to patient
and healthcare provider requests, Novocure evaluated TAs with tan colored bandage material
(Figure 1D) to minimize the stark appearance of the white TAs for patients and making the TAs
even more amenable for use in public settings.
Methods Results

Figure 1. Optune systems showing the portable electric field generator, rechargeable batteries and charger,
carrying case, along with the white (1A) and the newly designed tan colored (1B) transducer arrays (TAs).
GBM patients shown wearing the white colored TAs (1C) compared to the new tan colored TAs (1D) that are
designed to be less conspicuous for daily wear.
The purpose of this study is to evaluate the patient user experience with the change in color of
the TAs from white to tan.

 

This study was carried out in patients receiving Optune therapy for GBM. Twenty-five patients in Germany were enrolled prospectively and completed
a questionnaire (Figure 2) at baseline and regularly scheduled follow up visits over a 1 month period.
Patient Characteristics for Inclusion:
• Patients with newly diagnosed or recurrent GBM
• Cognitive function - Ability to read and write German
• Performance status minimum KPS > 70
• Caregiver support available
• Skin intact at start (mild redness allowed)
• Willingness to sign consent, agreeing to take photographs of the skin at several different time points
Study evaluations included:
• Patient reported responses to the questionnaire at day 0 (white arrays) and days 7 and 28 (wearing the tan arrays) with a focus on adherence of
the arrays to the skin, overall comfort, and cosmesis
Data analysis:
• Median change from baseline in responses to questionnaire compared using a Wilcoxon signed rank test

Figure 2. Patient questionnaire designed to assess user experience with the new tan TAs compared to their
prior experience with the white TAs.

Figure 3. Mean responses to patient questionnaire comparing baseline responses (after using the white TAs)
compared to patient responses after 28 days of using the tan TAs.

Questions Median difference from
baseline (range)
Wilcoxon Signed
Rank P-Value
Wearing the arrays with no head cover is: 1 easy 10 hard 0.0 (-3-5) 0.5098
When wearing the arrays I 1 not likely to cover my head 10 very likely to cover my head 0.0 (-6-8) 0.3264
When I leave the house I: 1 always cover my head 10 never cover my head 0.0 (-4-9) 0.2109
The color of the arrays: 1 too light, 6 just right, 10 too dark -3.0 (-5-0) <0.001*
The color of the arrays is: 1. very important 10 not important 2.0 (-4-8) 0.0110*
The liner on the arrays is: 1 hard to peel 10 easy to peel 0.0 (-7-9) 0.5498
When wearing the arrays my head feels: 1 cool 10 warm 0.5 (-3-5) 0.0424
I feel the arrays stick to my head: 1 very well 10 very poor 0.0 (-6-7) 0.7927
My device alarms: 1 frequently 10 never 1.0 (-9-3) 0.7268
When I wear the uncovered arrays I feel that they are: 1 easy to see 10 hard to see -2.0 (-8-8) 0.0052*
How comfortable do the arrays feel on your head: 1 very comfortable 10 very uncomfortable 0.0 (-7-3) 0.6513
Placing the arrays on my head is 1 easy 10 hard 0.0 (-3-7) 0.9407
Every how many days do you replace the arrays? 1 through 10 0.0 (-1-1) 1.000
0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0
Wearing the arrays with no head cover is: 1 easy 10 hard
When wearing the arrays I 1 not likely to cover my head 10 very likely to cover my head
When I leave the house I: 1 always cover my head 10 never cover my head
The color of the arrays: 1 too light, 6 just right, 10 too dark
The color of the arrays is: 1. very important 10 not important
The liner on the arrays is: 1 hard to peel 10 easy to peel
When wearing the arrays my head feels: 1 cool 10 warm
I feel the arrays stick to my head: 1 very well 10 very poor
My device alarms: 1 frequently 10 never
When I wear the uncovered arrays I feel that they are: 1 easy to see 10 hard to see
How comfortable do the arrays feel on your head: 1 very comfortable 10 very uncomfortable
Placing the arrays on my head is 1 easy 10 hard
Every how many days do you replace the arrays? 1 through 10
Mean Value of Question Responses: Baseline vs. 28 Days
28 Days
Baseline
Figure 3. Mean responses to patient questionnaire comparing baseline responses (after using the white TAs)
compared to patient responses after 28 days of using the tan TAs.
Table 1. Statistical analysis of the change from baseline in patient responses to questions assessing the user
experience with white TAs compared to the tan TAs.

Figure 4. Patient responses demonstrating a significant change from baseline (using the white TAs) in the
users experience with the new tan TAs.

Conclusions

The results of this analysis show that patients found the color of the TAs to be an important
attribute and that the tan arrays were less conspicuous. The participants in Germany found
the color tan color was neither too dark nor too light. The participants felt that the tan arrays
were significantly less warm while wearing. The Optune device is designed to minimize the
treatment effect on patients’ activities of daily living. Results from Phase 3 clinical trials show
that efficacy of TTFields is correlated with an optimal daily duration of treatment (>18 hours/
day). Therefore, improvements addressing the GBM patients’ user experience with the tan
colored TAs, which minimize calling attention to the patients’ medical condition, may help
improve treatment compliance and patient satisfaction. Based on these results GBM patients
in Europe are currently being switched to the tan TAs.

Corresponding author: [email protected]
Presented at Oncology Nursing Society's Annual Conference - May 17-20, 2018 Washington, DC

 

 

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