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Clinical Trials – Patients ARE Heard in the Process

Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Auroro, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.


Bravo to Patient Empowerment Network for providing cancer patients the program series, Mythbusters on Clinical Trials. [NOTE: Segment #3 to be broadcast Sept 6th, 2017 – see program link to register concluding this blog].

Without access to this type of content, how else would patients like me know the value or merits of participating in a clinical trial? Especially a patient like me, who worked in an academic medical facility, recruiting patients for clinical trials for a different medical speciality before my cancer diagnosis. Even I did not have a fundamental understanding of the benefits for me and my diagnosis.

I did have a fundamental understanding of my dire cancer prognosis however. It was as grim as our worst fears. The best option of care presented in that initial oncology consultation was palliative and comfort care measures for my remaining months. I was deemed inoperable due to the extent and metastatic spread of my disease. Even front line chemotherapy was portrayed as uncertain for my rare cancer form, Primary Peritoneal Carcinomatosis (PPC). At least, no evidence-based medicine with a large population of survivors, longevity to discern average duration of progression free disease, let alone, studied in depth enough to provide statistics with any degree of confidence.

The topic of clinical trials was brought up by me, not my oncologist. His response, “Clinical trial enrollment and acceptance can be a lengthy process.” In the subtext, all I heard is that he thought I would be dead before I was enrolled.

However, what my Oncologist didn’t know was that death not an option for me. Not only had I underwent a total hysterectomy due to my history of uterine growths and familial risk factors, including the BRCA1 mutation and extensive extended family cancer; I had already lost one sister to early onset ovarian cancer.  I aso had a second sister who had ceased treatment due to unmanageable side effects from two forms of breast cancer. I knew our family could not withstand another devastating loss to cancer. My parents are elderly and the grief from having lost one daughter with another hanging in the balance if remission would come; adding myself to the mix just seemed another cruelty to hard to deliver.

Fortunately ~ something went right for me early in the process. I was fast-tracked within ten days into a clinical trial, and my treatment started within two weeks. It was a Phase 3 clinical trial of combination therapy including a platinum-based chemo https://www.drugs.com/mtm/carboplatin.html

a second anti-neoplastic chemo

https://www.drugs.com/taxol.html

and a VEG-F inhibitor

https://www.drugs.com/avastin.html

all proven to work effectively together, but with a power boost, a new to market oral agent called a PARP inhibitor.

https://www.drugs.com/drug-class/parp-inhibitors.html

The beauty and greatest appeal of this particular clinical trial, and is a constant in many trials available to cancer patients today; is it fell into a Phase 3 or higher, did NOT include a placebo arm and was comprised of all known, effective agents. The purpose of the study was to identify in what frequency and dosage all worked best, not whether they would have efficacy. I knew what was being tested, which drugs were incorporated and what outcome (dose, frequency parameters defined) was expected. I was impressed at the degree of information captured, analyzed and monitored throughout my clinical trial. Never once feeling at risk of an adverse event or my identity compromised. nor, never once did I feel I did not have the power to suspend my participation if I felt any risks.

Oversight comes from many places, including national and state foundations and organizations with the 100% directive as guided by the principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report) [https://www.hhs.gov/ohrp/]. Reviews of research are performed in accordance with the Department of Health and Human Services (HHS) regulations 45 CFR 46 (also known as the “Common Rule”) and the Food and Drug Administration (FDA) regulations 21 CFR 50 and 21 CFR 56.

https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/ucm155713.htm

I experienced an exceptional response on the clinical trial. My specific cancer marker fell from a pre-treatment high of nearly 3,000 (normal range value = 0 to 35) to 200 within the first six months. While I wish I could conclude this section saying I’ve since been cancer free or in remission. It was a short-lived response. I had disease progression the following year, but I never regret being on that clinical trial. In fact, still today, the PARP inhibitor component I was responsive to in my clinical trial, is still a core of my current treatment plan.

I can say with confidence, I am here as long as I have been by being receptive to clinical trials. That first trial, while ultimately not my cure, bought me time until the PARP inhibitor was approved by the Federal Drug Administration (FDA) for provisional production and release to patients failing 3 or more front-line treatments. As, unfortunately, following the clinical trial, after invasive surgery and debulking, intraperitoneal cancer, I had yet another round of disease progression. I also say with confidence, that first clinical trial was just my first bridge to conventional treatment and surgery.

I’ve played an informed game of leapfrog from clinical trial to conventional treatment to surgery, back to clinical trial and back into conventional treatment. Each clinical trial yielded powerful information about my responsiveness to alternative and combination therapies that proved integral to my next treatment plan.

The result being that I am here today to tell my tale. Six months is now 5 years and 6 months down the path of my cancer experience. A clinical trial was not – has not yet – provided my cure. But having these bridges to new options that were not available to me six months earlier, is not a back track record in my mind.

It still astounds me however, of the estimated 20 – 40% cancer patients who meet criteria for clinical trials, only 3-4% enroll.

https://www.standuptocancer.org/innovations_in_science/view/the_ins_and_outs_of_clinical_trials

I am far from considered an expert on clinical trials, have passed certification and credentialing for enrolling patients and performed data collection in my past role, but my most powerful opinion is based upon personal experience. Being afraid of being used as a guinea pig is an era far receded into the past. Today’s clinical trials are more innovative and more effective than ever. If a clinical trial buys you even 1 week or 1 month of quality time, I say it’s worth it. Even if I were a guinea pig in the process, my vote is that it would have been worthwhile. I would just have chosen to be the squeakiest among the bunch!

See us live on this topic!!

https://www.patientpower.info/event/myth-busters3

It’s Not About Vanity, It’s About Identity

Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Auroro, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.


Appearances do matter. Let’s face it. Whether we like to admit it or not.

My appearance has always mattered to me. But cancer takes over your appearance, forcing you face an unknown entity in the mirror. Even with average looks and physique, I was always comfortable in my skin. Until cancer.

I dreaded hair loss as many do, but little did I know there was more to dread.

How I wish someone had told me losing your hair is minor, wait until you lose your eyelashes and eyebrows. Hair aside, the eyes are the gateway to your soul. My eyes without the familiar frame of eyelashes and eyebrows look distant, shallow and colder. I became a face no longer recognizable even to myself.  

The injury added to the insult is my body ravaged with scars. Each day brings a new blemish in some unexpected place. Bruises even on the tops of my feet. Aches and pains so deep no topical or pain medication can even touch it. A body that wants to lie in bed all day.  I don’t want this to be my body. I don’t know this body.

My scalp feels constantly agitated as hair grows back. Yet, I can’t run my fingers through wavy, soft hair, it’s a mere patchwork of kinky, coarse sprouts of regrowth. I can compensate. I can wear my “hair” aka ‘a wig’. I have scarves, headbands and hats to rival any celebrities accessory closet.  But I’ve lost the appearance that used to be uniquely me.

Wigs itch, as do most hats. Scarves are equally obviously just covering the sparseness underneath. All just poor attempts to mask the reality anyway. When in public with any headwear it’s impossible not to be self-conscious. Some days I think, certainly I shouldn’t have to put on this façade. But I do. Day after day.

And why is that? Aren’t we living in a more enlightened period? We’ve moved stigma of cancer beyond whispers and shushing in society to being more vocal and “out” about our disease, haven’t we?

Sadly, not completely. When I was completely bald, I did my own social experiment if you will, I ventured out with the least possible masking of my illness. Just a simple hat. No attempt to conceal my pinkish scalp. No fake bangs or wisps of hair to falsify it. No attempt at false eyelashes or painted on eyebrows. Just me trying to be bold.

Everywhere I went. Eyes averted mine, no one looked me in the eye. The store clerk pleasant enough, kept turned from direct eye contact. Other shoppers browsing, fixated on store racks instead of acknowledging me. I caught a few stares, but when I smiled at them to ease the awkwardness, they just looked away as if caught in some sinful act instead of pure curiosity.

For the first time in the span of an entire day, not a single stranger approached or spoke to me. What an isolating way to go through a day. Was it just me giving off the vibe of unfamiliarity and therefore calling it to me? Who’s to say or know? But it didn’t feel good. Experiment failed.

So, I put my hair back on and join friends who accept me with or without hair. An act that is not about vanity, it’s about identity. Cancer can strip you of the visual aspects that we attribute to vanity. But when cancer not only reflects the disease inside, but projects a spirit uncharacteristic of you to the outside, it becomes about your identity.

In the moments we find to escape our illness; the music can play, the rain can stop for the sun to shine through again, the rainbows can appear. But amid the laughter and smiles, no one has any idea of the burden of sorrow on the mind and soul of those in the cancer experience. They go home at the end of the day, reflect on their worries that while significant are typically not about life or death. We go home at the end of the day and have to study meds to make we’ve stayed on schedule. Feel distress at the new pile of bills and claims owed. Play catch up with the pain or nausea. Then we try to settle into bed and clear our minds of the gravity of the living with a lethal diagnosis.

My hope is that instead of internalizing the slights of strangers, we can find it an interesting study in human behavior. Or the next time we see someone in an obvious state of illness, we can make eye contact, extend a compliment, or project a smile. Don’t let any appearance dissuade you from doing so.

The DisCONNECT OF CANCER

Editor’s Note: After a long and resilient battle with primary peritoneal cancer, Roberta Aberle, 53, of Aurora, CO passed away on November 1, 2017 with her husband David Oine at her side. Even as she battled her own cancer, Roberta was a tireless advocate for patient care, hoping to improve the lives of others also fighting life-threatening illnesses. She will be greatly missed by all who knew her.


The descriptions of first hearing “you have cancer,” all follow a common thread – shock, denial, surreal, as are the emotions and reactions to the news – disbelief, despair, fear. However, I suspect few people ask themselves in those initial stages of grasping the news, “I wonder how many people I care about will disappear from my life as I fight cancer?”

But it happens. I hear it over and over, with dizzying similarity. I was one who never even contemplated the idea any of my loved ones would not be there to through my cancer experience. But it happened to me immediately, gradually and then again abruptly, long after I was down the road of treatment.

And I never saw any of it coming.

At first, there were the expected disappearances. Colleagues, neighbors and distant friends, upon hearing the news either would at first react with sympathy, then the avoidance began. A random colleague would pile up his papers and laptop before the meeting ended and be up and out the door with barely a nod to me. I’d be out walking my dogs and see a neighbor coming around the corner – not realizing I’d seen them – turn to walk the other direction. The e-mail update and invitation to follow my fight on MyLifeline.org site went unacknowledged by more than a handful of long term friends. One couple I had introduced to each other and later married, I’ve not seen or heard from during this 5+ year odyssey. Another couple my husband and I went out with rather regularly at first were adamant they would be all over me helping. I heard from them daily the first week, the last call being to find out what type of soup I preferred. The soup never came. Nor did they, ever again.

Both are still receiving my emails and updates, they never come back undeliverable, I see their updates on social media, so I’m confident they are alive and well. For whatever reason, they’ve chosen not to be a part of my path.

At first it hurt terribly, then I did my best to employ all the psychological and human behavior knowledge I’d gleaned throughout my life.. It was easier to understand once I divorced myself from the hurt and focused on what defense mechanisms those absent friends were using.

Most people don’t know what to say or how to say it. So they avoid the topic entirely. And in the case of cancer, where it’s next to impossible to avoid the topic because it can be all consuming; avoidance of me, as well as the topic seemed to be the natural conclusion.

Even with that understanding of the likelihood absence was their defense, it doesn’t change how much I  miss them, I miss knowing about their lives. I miss their energy and spirit. I miss their friendship.

There are the people who show up in the grand way which helps you cope with those who can’t show up. The support system that come over, pick up the phone to reach out, send cards, books and other resources. Asking for ways they can offer help. Wow. Mind boggling how some people will come out of the woodwork.  And how fortunate we are for those who do.

Then there are the very sad stories of cancer totally wrecking you to your core. Those, for me, were the ones that came quite abruptly later. But in my travels and exposure to cancer patients near and far, I’ve heard about spouses serving divorce papers, children who lash out and misbehave, parents who aren’t present at chemo sessions or surgeries, friends who drop you from social gatherings. The entire gamut. How do you explain these crucial relationships that come crashing down?

Over my 5+ year battle, even a handful of those who stepped up in the most generous and productive ways eventually disappeared too. I barely have had the stamina for this duration of time, how could I ask anyone else to? But there are equally just as many who were there are Day 1 and are still here on what is around Day 1,991. For all of them, I’m eternally grateful. They have carried me through.

But back to those significant relationships that collapse, what logic explains those? Not being an expert in the field of human psychology, I can only comment based on my own personal circumstances

For me, it was two nearly life long friends who left my side with extreme abruptness and even more extreme callousness. Amid harsh words both of them, who did not know each other, accused me of using my cancer as an excuse to be horrible and nasty to people. Furthermore that they only stayed friends with me due to feeling sorry for me having cancer. Wow. One went so far to say how sad it was I needed help with my laundry and who really did I know who would want to launder my dirty underwear? True and unfathomable.

My personal interjection here is: where is the compassion and where is the sensitivity? I have a terminal diagnosis, even if I were a bad person to be around during my cancer, wouldn’t a true friend help you identify and seek out ways to help you cope differently? What motivation and impure intent has to be behind hurtful and hateful words that are spewed knowing the dire circumstances of a person they claim to love and care for? Would you say such things to a person with life threatening heart disease, addiction or diabetes? How does going for the jugular help the person in a medical crisis? How does deserting them help power them through healing to a cure?

Those are the questions to ask yourself when you seek to recover from the abandonment of anyone significant while you are struggling with cancer. What would a reasonable person do in the same situation? How would they help you cope and manage? Would they put hurtful, hateful adjectives around you and blame you for your plight?

No.

Is it possible they had to create conflict with you to push you away because they couldn’t bear to see you suffer?  Or because they couldn’t fix it? Or because they were sheerly self-referential, unable to cope with mortality, yours or their own and just wanted to be free of the confines cancer can bring?

In other words, odds are, it’s not you, it IS them. I wish I could wave a magic wand and tell every person who has leaned on my shoulder, who has confided to me in tears about who has left or worse, their words, who has “rejected” them since their diagnosis. Every story of this nature, pierces my heart again as if it were happening to me all over again.

All I can do is suggest that as painful and prickling as it is, hold your head high. You did nothing to deserve being abandoned nor did you cause your own cancer. If a significant person in your life cannot walk through the fiery coals with you and carry you if needed, you do not need them there with you. It is not an easy lesson, and trust me, I replay it over and over as to what I did wrong and should’ve done differently; all the while knowing the outcome would likely be the same. They may have left anyway.

There are thousands of quotes and adages about allowing another person to leave when they want to leave. For whatever reason. The true and pure individuals will return. They may or may not have answers for you as to what or why they were driven to desert you. This would be the happiest conclusion, the true meaning of closure.

The best way to view this situation when and I hope, only IF it happens to you; you sweep all the negativity and the pain of it aside. Allow yourself to immerse yourself in those who can be present, who do show up, otherwise you’d be preoccupied with hurt to invest in the people who can put aside their own needs, who can sacrifice their own potential for hurt and loss to be there without reservation, without stipulations and without complaint.

Then the decision belongs to you, whether you welcome them back into your life or not. I’ve asked myself, if ever had the chance to reconcile with the immediate, the gradual or the abrupt departures could I or would I? It remains to be seen as it hasn’t happened yet. All I can predict is that, for me, and this is only me, it would be hard to edit out this huge segment of my life and resume a friendship the way it was. It doesn’t mean it can’t be a different relationship, but it also doesn’t mean it could never be resurrected. But I don’t have to worry about that right now. If it ever does happen in my lifetime, I will be sure to let you know what I choose to do.