A Patient’s Perspective on Clinical Trials

breast cancer patient

Celine Delaloye

(Editor’s Note: This article is in two parts. This is Part 2 (go here to read Part 1) and consists of an interview of Celine Delaloye, a professional working at a pharmaceutical company and an HER2 breast cancer-positive patient. The interview is conducted by the “Indomitable” Christine Bienvenu, breast cancer patient, avid patient advocate and board member of the Patient Empowerment Foundation, our sister organization under development in Europe. And please, don’t be concerned that this is an interview with a European patient. You will be surprised to see that the issues, thoughts, concerns of patients and doctors are the same. These issues are worldwide!)

As a professional working in a pharma company, Céline Delaloye (28) is no stranger to clinical trials. Here, she discusses her personal experience as an HER2 breast cancer-positive patient.

Interview With Celine Delaloye

breast cancer patient

The Indomitable Christine Bienvenu

Christine Bienvenu (CB): How did you learn about the clinical trial you are part of, and what convinced you to enroll in it?

Céline Delaloye (CD): It was thanks to working for a pharmaceutical company that I first heard about the clinical trial, and given my job, I’m well aware of how difficult it is to enroll in trials – let alone get accepted. As a professional, I’ve drafted many a quality of life questionnaire for clinical trials, and my professional insights really helped me when I, all of a sudden, was a patient myself.

My oncologist explained to me what a Phase II randomized study was, with the “random” part meaning that I couldn’t choose which group I’d be part of. Again, thanks to my professional background, I already knew a lot and didn’t need further convincing. But for my husband, it was really important to get a second opinion. Luckily, the oncologist we met with spoke very highly of the clinical trial, boosting our confidence about it being the best possible treatment available.

 

CB: Because of your job, you’ve seen how difficult it can be for patients to meet Phase II clinical trial eligibility criteria. Does that make you feel fortunate about access to the clinical trials, or frustrated that more patients can’t benefit – or did you even think about that at all?

CD: Like you said, I knew from my professional background what I was up against. My husband, though, was afraid I’d be used as a “guinea pig”. And it’s when I heard those words – “guinea pig” – that it struck me how the words “clinical trial” can really scare people. They’re in the dark about the details; to them, it’s like some kind of experimentation.

I honestly feel very fortunate that I was accepted into the clinical trial because I had the “luck” – if you want to call it that – of meeting all the criteria. I’m proud and happy to be part of a clinical trial. But I’m fully aware of the fact that not everyone has the same opportunity.

 

CB: How did you feel when you were accepted: Happy or apprehensive? What were your hopes and fears when you enrolled in the clinical trial?

CD: Initially, I was really happy in the sense that there was no doubt at all about my meeting all the acceptance criteria for the trial. I was excited. Scared. A bit of everything. My professional experience pushed me to learn as much as I could about the clinical trial.

To be honest, though, as a patient, I just needed to understand every aspect of it. But when I started reading all the documentation related to the study, its possible side effects and outcomes, I became more apprehensive: Which ones would I have? When I started the first cycle, though, I realized that we’re all unique in how we react. Just because potential side effects were listed didn’t mean that I’d have them. Two treatments in, I saw that I wasn’t experiencing every side effect, and felt more reassured about continuing the treatment with confidence.

And oh my goodness, the paperwork! I found it completely overwhelming, to be honest. But I just took it one step at a time. That’s the only thing you can do, really.

 

CB: Be honest, how hectic were the logistics of being part of a clinical trial?

CD: As a professional, I hadn’t had to deal with the emotional component of being part of a clinical trial. As patient, I did. As a patient, at intellectual level, I needed to understand all of the protocol tests associated with clinical trials to feel reassured and feel confident about continuing.

To be honest, I was never discouraged by the number of appointments related to the clinical trial. Sure, logistically, I needed to make sure my baby and husband were okay, but I have an amazing network of family and friends who have supported me throughout. At no time have I wanted to stop treatments: I’m more of the mindset of, “The faster we start, the faster the results”, right?!

 

CB: How supportive was your medical team in helping you deal with logistics?

CD: They were amazing, across the board – seriously. All the oncologists and nurses were so accommodative of and flexible with my schedule, needs and requests. They really made my life so much easier. Keeping up the busy pace of appointments was never an issue.

 

CB: Based on your experience, what would you tell anyone considering enrolling in a clinical trial?

CD: As both a professional and a patient, I’d encourage others to look into clinical trials, gather extensive information, ask their oncologist questions, and go for it. In my mind, it’s the best thing that can happen, treatment-wise. But I know how difficult it can be for so many, given just how stringent the acceptance criteria are. And for me, that’s a problem. Get out there, don’t sit back. Be proactive! Learn everything you can… Talk to your doctor: in my view, as patients, we’re a crucial part of the team!

 

CB: As a patient, do you feel information about clinical trials could be more available or easily accessible?

CD: Personally, I think every patient should be informed of any study, regardless of eligibility or where they are being treated. It is both the patient’s and the doctor’s responsibility to learn about clinical trials. When you are first diagnosed, your world crumbles. But information is knowledge and power… It’s so important. In my view, all hospitals – university and private – should be part of raising awareness in patient circles about clinical trials by hosting regular information sessions. If patients had easier access to information on clinical trials, I think they’d be naturally more inclined to look into their eligibility.

Another aspect that I think is often overlooked – but very important – is this: If a patient isn’t accepted into a clinical trial, what support networks are available for them? They have just as many hopes as the rest of us and shouldn’t be left behind. I was just lucky enough that I qualified fully for the clinical trial, so this deep disappointment wasn’t ever anything I had to deal with. I feel very lucky in that respect. But I do wonder about the support network for those patients who don’t qualify.

 

CB: Any parting thoughts?

CD: As a patient, it’s important to remember that when you accept to be part of a clinical trial, you also have every right to back out – at any time. It’s also important to know that if the disease progresses, a patient runs the risk of being removed from the study. I also firmly believe in the patient being proactive and informed every step of the way.

 

The National Cancer Institute’s (NCI) “10 step guide on how to find a cancer treatment trial” helps patients better understand what clinical trials are all about, how to talk to their doctors, and know what questions to ask, visit: http://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide?cid=tw_NCIMain_nci_Clinical+Trials_sf39211784

An Oncologist’s Perspective on Clinical Trials

(Editor’s note: This article is in 2 parts. This is Part 1 (go here to read Part 2) and consists of an interview of Dr. Anita Wolfer, Senior Oncologist and Head of Unit in Oncological Research, Lausanne University Hospital (CHUV). The interview was conducted by the “Indomitable” Christine Bienvenu, breast cancer patient, avid patient advocate and board member of the Patient Empowerment Foundation, our sister organization under development in Europe. And please, don’t be concerned that this is an interview with a European oncologist. You will be surprised to see that the issues, thoughts, concerns of patients and doctors are the same. These issues are worldwide!)

Great progress has been made today in immunotherapy and targeted therapies – especially in cancer research – thanks to patients having access to clinical trials. It is crucial that patients learn about their options.

Interview With Dr. Anita Wolfer

The Indomitable Christine Bienvenu

The Indomitable Christine Bienvenu

Christine Bienvenu (CB): How do clinicians learn about clinical trials?

Dr. Anita Wolfer (AW): It depends very much on where they’re working: Doctors in university hospitals are constantly informed of clinical trials. Their peers outside the hospital environment are not, though: It’s up to them to actively find clinical trials and stay informed.

 

CB: Here in Switzerland, are there formal protocols in place for spreading information about clinical trials?

AW: In terms of the medical system, there aren’t any formal protocols on doctors being up to date on clinical trial options. I think it’s important that university doctors take it upon themselves to keep their non-university environment peers informed. Often, unfortunately, those oncologists working outside the hospital environment only think of clinical trials when conventional treatments have failed. For researchers like us, it’s more second nature to turn to them for treatment options.

Here in Switzerland, the “Réseau Romand d’Oncologie” (Western Switzerland’s oncology network) centralizes all the information about clinical trials, and keeps it updated. For the new Swiss Cancer Center Lausanne (SCCL) opening in 2017, its director, Prof. Coukos’ vision is simple: All information – clinical trials, research, collaboration, and participatory medicine – should be accessible to patients and professionals alike.

 

CB: When and why do clinicians talk about clinical trials to their patients, and how do you view the patient’s role in trials?

AW: Often today, oncologists will only talk to a patient about clinical trials if they see that there’s a direct benefit to the patient. But in my view, it’s important to inform the patient of the clinical trial, regardless so that they too can look into the application process. In an ideal world – and I say this as an oncologist and clinical researcher – there would be a clinical trial for every patient who walks through our doors.

As for the patient’s role, I’m a firm believer that sharing is building in this profession. Patients are crucial in this process: No-one knows their bodies better than they do. The way I see it, any patient of mine gives me the opportunity to learn. I don’t want to waste that.

 

CB: What obstacles do clinicians face in conveying clinical trial information to their patients?

AW: Unfortunately, some oncologists are afraid that university doctors might “steal” their patients, so they don’t readily refer them for fear of losing income for their own hospital. With patients being so closely followed during the clinical trials as well, this is comforting: Often, they’d rather not go back to their ‘regular’ oncologist. In my view, it’s a shame to look at it that way: If there’s a relationship of confidence and trust with their primary oncologist, if patients know they will get all the necessary information, they’ll be more inclined to stay with their respective ‘regular’ oncologists. To be brutally honest, my feeling is if an oncologist is upset about a patient seeking a second opinion, then maybe it’s time to find a new oncologist? It happens in the medical profession: I’m not immune to it – no-one is. But it shouldn’t be an issue… Just like in any relationship, if the doctor/patient relationship isn’t working out for the patient, he or she has every right to move on.

 

CB: In your profession, how important is mindset – in both the patient and the doctor or clinician?

As in any profession, or with any patient or co-worker, there are always those who are willing and excited to go the extra mile. If the mindset to do so isn’t there, there really isn’t much that either a patient or an oncologist can do in terms of moving forward. A pro-active mindset is crucial.

 

CB: In the same vein, how important is mindset in clinical trials, then?

AW: Being convinced about the clinical trial is also very important – not only for the patient, but for the doctor. A well-informed doctor means a well-informed patient. Speaking for myself, I’m constantly on the lookout for the best treatment options for my patients – even if it’s a clinical trial outside the CHUV. Why wouldn’t I? It’s about moving forward in cancer research, not about being territorial with knowledge.

 

CB: What role, for you, does the sharing of information and access to clinical trials play in patient mindsets?

AW: Armed with information, most patients are willing to be a part of trials – even if it isn’t one they had specifically hoped for. Time and again, we’ve seen how patients who participate in clinical trials usually have better outcomes than patients who don’t. Beyond the obvious rigorous monitoring, the crucial element here is that the patients feel more responsible for, and engaged in, their care. What strikes me, time and again, is that clinical trials offer hope. And while not every clinical trial story is a positive one – with frustration and heartbreak often integral to the process – hope is a crucial element and great motivator.

 

CB: Getting into clinical trials is no small feat. What improvements, if any, would you suggest? Can patients be better-informed about clinical trials?

AW: In an ideal world, there would be a clinical trial for every patient. One of the objectives of the CHUV oncology department is to have a portfolio of trials so that there are alternatives for every patient. And despite limited resources, the department is working hard to open up a maximum of number of trials. Also, with the SCCL opening up in Lausanne, more research funding is coming in, and more specialised oncologists are coming on board.

 

CB: What for you is a key component of a successful patient/clinician or doctor relationship?

AW: Ultimately, it’s about trust, confidence and collaboration. And going back to your previous question, if patients feel they’re being fully supported by their oncologist, they’ll return to them – university hospital setting or not. To me, it’s extremely important that patients take the necessary steps to establish the relationship of trust that they seek.

 

CB: What feedback have your patients given you about their experiences in clinical trials?

AW: Some patients will say outright that they’re not interested. But the vast majority – I’d say 70-80% – are willing participants. So far, I’ve only ever had one patient tell me she wasn’t happy with a clinical trial. For most, it goes beyond participating for their own benefit, per se: it’s about being part of a greater cause and helping medical science advance. Patients are genuinely altruistic. What is clear, though, is that it’s a team effort that involves the patient and the medical community.

 

CB: Where can patients find information about clinical trials?

AW: There are a number of great resources out there. In no particular order, I can suggest the Swiss Group for Clinical Cancer Research (http://sakk.ch/en/) or Clinical Trials (https://clinicaltrials.gov/) which is a service of the US National Institutes of Health that lists all the studies being done in all 50 US States and in 190 countries.

Here in Switzerland, there are obviously the Lausanne University Hospital (CHUV: http://www.chuv.ch/) or the Geneva University Hospital (HUG: http://www.hug-ge.ch/) websites. Experience has taught me that the university websites are sometimes a bit outdated, but patients can send emails directly to oncologists there and should get an answer.

 

CB: Any parting words of wisdom?

AW: Patients never doubt themselves in asking questions. There is no such thing as a stupid question. If a patient isn’t having his or her questions answered, he or she has every right to find someone who will! Questions are crucial: They lead to greater understanding, knowledge, and progress.

Also, it’s important to remember that in Clinical Trials, limits have to be set to be able to provide realistic results. Make the criteria too broad, and it becomes difficult to show a trial’s effectiveness. With immunotherapy, clinical trials broaden patient eligibility. Granted, a patient needs to be healthy enough to be able to benefit from a trial, so if for example a patient is in palliative care, they wouldn’t be eligible – unless, of course, the clinical trial is in palliative care.

The National Cancer Institute’s (NCI) “10 step guide on how to find a cancer treatment trial” helps patients better understand what clinical trials are all about, how to talk to their doctors, and know what questions to ask, visit: http://www.cancer.gov/about-cancer/treatment/clinical-trials/search/trial-guide?cid=tw_NCIMain_nci_Clinical+Trials_sf39211784

Getting a Second Opinion

“Get a second opinion!”

This is important! Who doesn’t get a second opinion when having work done on their car or house? Isn’t your body and health more important!

Go to a specialist and get a second opinion. Travel the distance if need be. Your health is so important. You don’t have to be followed up on every visit by a specialist if you live far away, but you owe it to yourself and your loved ones to have a specialist on hand as the “architect” of your healthcare treatment plan. Cancer is a serious disease and the specialists see only cancer patients day-in and day-out – they are the ones who keep up with the latest news and treatment options. They are the ones who have access to clinical trials and can let you know all the options there.

Watch the following video from our recent town meeting for lung cancer patients and listen to the panel discuss the importance of getting a second opinion:

Getting a Second Opinion from Patient Empowerment Network on Vimeo.

A Clinical Trial as a Positive Experience

During the fifth session of Patient Cafe™, Mike talks about his initial diagnosis and his feelings during that time. Mike had no symptoms of his disease and was on watch and wait. He felt fine but was concerned that his healthcare plan did not give him access to a CLL specialist. He switched plans in order to get a second opinion and ended up seeing Dr. Rosen from City of Hope who helped him enroll in a clinical trial.

Mike had a very positive experience during the clinical trial. He had almost no side effects and responded well to the treatment. When asked what he would tell other patients who were perhaps a bit afraid of enrolling in a trial, Mike answered that it is very easy to be afraid if you read about all the horrible side effects that are possible. But if you talk to the medical team and ask them what is most likely to happen, they will give you a pretty good idea.

Watch the video and listen to Mike relay his experience:

A Clinical Trial as a Positive Experience from Patient Empowerment Network on Vimeo.

The Bureaucracy of Clinical Trials

At a press interview with Dr. David Stewart, Head, Division of Medical Oncology, University of Ottawa, Dr Stewart laments the extreme inefficiency of the clinical trial process. Patients are dying while government is regulating. The clinical trial process is too long, too costly and too inefficient. Watch this video from The World Conference on Lung Cancer that recently took place in Denver, Colorado:

The Bureaucracy of Lung Cancer Clinical Trials from Patient Empowerment Network on Vimeo.