Q & A to know - answers allowed to say to HCP/Pts Flashcards

1
Q

How many hours/days/months do I have to wear the device?

A

I am Technical Support for the NovoTTF-100A system only and any medical questions or questions regarding treatment should be directed to your doctor.

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2
Q

When you tell patients their compliance %, they ask you what that means. How should you respond?

A

Your compliance percentage should be discussed with your doctor.

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3
Q

A patient call and states he is having alarms and it has been 4 days since the last array change. You recommend they try an array change, but the caregiver is gone until later that day and not available for an array change. The patient asks, “Is it OK if I just turn it off until my wife gets back to change the arrays?”

A
  1. Let me see if we can troubleshoot to make sure it is not an issue with any of the equipment.
  2. Is someone else available that can assist with the array preparation (if needed; if geographically feasible, offer to come out to assist in array preparation).
  3. I can’t give permission to take time off of treatment. Please contact your physician for any questions or concerns regarding your prescription.
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4
Q

A patient complains about the HCP/Site/Staff (non-novocure).

A

Inform your RM and provide details about what pt reports to you.

explain to the pt that you are technical support for the NovoTTF100A system and that any concerns about the site should be addressed with the site.

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5
Q

Patient calls you during the night and asks about medications that are OK to use and reports that chemo med making him nauseous.

A

Clinical: Explain you are technical support for the NovoTTF100A system and any medical questions should be directed to his doctor.

Comm: Explain you are technical support for the NovoTTF100A system and any medical questions should be directed to his doctor. Report medical complaint to Support@Novocure.com

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6
Q

DSS meets a patient for an array exchange and notices skin irritation. The day after, the DSS receives a call from a SC inquiring about details of the patient’s skin condition.

A

Clinical: Politely remind the nurse that you are responsible for technical training and troubleshooting and are not able to provide any medical information.

Comm: Politely remind the nurse that you are responsible for technical training and troubleshooting and are not able to provide any medical information. As needed, also get the CSL involved. In addition, a medical complaint should be submitted to Support@novocure.com

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7
Q

Briefly describe the DSS role

A

Provides Technical Training on the NovoTTF100A system to a patient, family member or caregiver and support the patient while on treatment.

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8
Q

Briefly describe Novocure

A

Novocure is an oncology company, founded by Dr. Professor Yoram Palti, in 2000, dedicated to the advancement of Tumor Treating Fields Therapy for patients with solid tumors.

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9
Q

Briefly describe the NovoTTF100A system

A

the Novocure TTF100A system is a completely new form of treatment for cancer. The NovoTTF-100A system produces alternating electrical fields within the human body that are inferred to disrupt the rapid cell division exhibited by cancer cells, with the alternating electrical fields applied ot the brain through transducer arrays placed on the scalp.

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10
Q

Does this treatment really work?
Upon compliance check, “Is it working so far”?
How does this treatment work?
How effective is this treatment?
How long will it take for the device to work?

A

This is a question that has to be discussed with your doctor. I am here to help you with any question that you might have related to equipment and troubleshooting. I am not able to provide any medical information.

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11
Q

How long do I need to be on this device? Hours, days, weeks, months?
So I only need to do 18 hours, after that I am good, right?
Can I turn off the device for (whatever reason)?
can I take a break in treatment?

A

Your healthcare provider has prescribed the NovoTTF-100A system and the duration of therapy is determined by him/her. Please consult with your physician.

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12
Q

Why do the devices keep malfunctioning? Does this happen a lot?

A

as with other electrical devices, the NovoTTF100A system can potentially be damaged. We have experts putting great efforts into improving the durability and mobility of this equipment.

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13
Q

Is there interference between the NovoTTF100A system and laptops/microwave/television/Wi-Fi/etc?

A

The NovoTTF100A system has been tested for a series of technical standards for safety and performance. This series includes electromagnetic compatibility which means testing to make sure the device does not improperly interfere with other electronic equipment or is interfered with by other electronic equipment. It is quite possible that some sensitive equipment is affected by the device if the affected device is not properly shielded (does not meet the same standards).

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14
Q

Can I use a car charger

A

The NovoTTF100A system is a portable battery operated device. The device is not designed to be plugged into a car charger. If you plan to be away from home for more than two hours, carry an extra battery and/or power supply with you in case the battery you are using runs out.

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15
Q

What should I do if I do get skin issues?

A

That’s a great question for your doctor. he or she will be able to discuss any matters with skin care with you. The only advice I can give is to shift your arrays at each exchange, keep your head well shaved, and apply alcohol before placing the arrays.

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16
Q

How many patients have been treated?
How many patients do you have on treatment?
How many patients do you have with this doctor?
Are there others like me in the area? Can I talk with them?
Please tell me about your personal experience with the device..how many patients do you have and how long have they been on it?

A

I am sorry, but due to confidentiality, I am not at liberty to disclose that information.

The number of patients on treatment in not information that is available to me.

17
Q

Is there an online support group or chat session to join?

A

As of right now, there isn’t a support group or chat room that Novocure endorses. But you can certainly reach out to your doctor and ask for local support groups.

18
Q

We would love to take you out to dinner. Would you like to join us?

A

Thank you so much for the offer, but due to company policy I must limit my role to only supporting you with the technical aspects of the NovoTTF100A system

19
Q

Am I going to die?

A

My role is limited to supporting you with the technical aspects of the NovoTTF100A system. This is a question you should discuss with your doctor.

20
Q

Doctor asks how many patients do you have on the trial?

A

The study EF-14 is still on-going, so I am really not at liberty to provide you with that information.

21
Q

Doctor asks if a pateint can use their smart phone to video the patient start?

A

yes, as long as it is complying with your policies, the patient is more than welcome to do so.

22
Q

Doctor asks what were the outcomes/results of past studies?

A

Sorry, but I am not able to answer that question. I can ask the (CSL = Commercial / Sharyn R = Clinic) to contact you to discuss you questions.

23
Q

Doctor asks what were the results so far with EF14?

A

That information is not available to me, but I can ask (CSL = Commercial / Sharyn R = Clinic) to contact you to discuss your questions.

24
Q

Doctor asks overall skin questions (Aloe vera on the skin vs. hydro-cortisone cream)?

A

Commercial: I will have the CSL contact you to disucss skin care.

Clinical: I will have Sharyn R contact you to discuss skin care.

25
Q

Doctor asks any protocol questions

A

I will have Sharyn R. contact you to disucss

26
Q

Doctor asks about EF-11 results

A

Commercial: I will have the CSL contact you to discuss.

Clinical: I will have Sharyn contact you to discuss.

26
Q

What is NovoTTF therapy?

A

NovoTTF Therapy is delivered by a portable, non-invasive medical device designed for continuous use throughout the day by the patient. The device, the NovoTTF-100A System, has been shown in in vitro and in vivo studies to slow and reverse tumor growth by inhibiting mitosis, the process by which cells divide and replicate. The delivery system weighs about six pounds and creates a low intensity, alternating electric field within the tumor that exerts physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death prior to division. NovoTTF Therapy is not approved for the treatment of brain metastases. The safety and effectiveness of the therapy in this indication has not been established.