Finding Clinical Trials: Tips For Navigating The Void

So anyway, back to being all alarmed and stunned at the gaping chasm in our medical system into which people with cancers that don’t respond to standard treatments fall…

My mom and I were talking about it last night and I was wondering if we are just feeling this incredulous because we’re so emotionally raw and psychologically freaked out.  No, she reminded me, this just isn’t the way it’s done.  Your GP doesn’t tell you to research which antibiotics to take to treat your strep throat. She identifies the best one for you. Yet there is no one anywhere in the system (at least not where I could find them) who’s job it is to research clinical trials on behalf of cancer patients. This is a resource that just doesn’t exist in one of the largest cancer research and care centres in the world, and the implications are frightening. 

It’s true that this is the most unsupported I have felt since that day in March 2008 when I was told I had cancer. But even if the system as a whole has failed me there are many individuals who have not.

I was helped by my oncologist, my family doctor, my family and many friends, the hospital social worker, nurses, and several other people. But none of these people was helping me research clinical trials because it was their job to do so.  It should be somebody’s job. Instead, it was my sister-in-law and some kind women at a breast cancer support organization called Willow  (where she used to work) who eventually found the Montreal study. My sister-in-law. Honest to god, just think about that.  And reach for the barf bag.

So, since I can’t fix the system from my laptop (at least not this afternoon) I think a summary of what we learned in the last couple of weeks is the best, most practical thing I can do for anyone else out there who might encounter a similar nightmarish tumble over the edge of the un-signposted cliff-face of cancer support:

1.   You’re not breaking up with your oncologist.  If your cancer doesn’t respond to standard treatments your oncologist no longer has anything with which to treat you.  However, he/she is still there for you in the following capacities:

  • to discuss ongoing, worsening or new symptoms and test them and try to treat them
  • to connect you with oncologists responsible for any clinical trials available within your hospital network
  • to review any clinical trials you find on your own and vet them for suitability
  • to talk with other doctors, nurses or people on your medical team
  • to process your applications for clinical trials (once you have identified them)

2.   No harm in asking. Remember that the Hippocratic Oath begins, “First, do no harm” – and now proceed to shamelessly use that to your advantage. Even though it is not your oncologist’s job to do it, you can ask him/her to research clinical trials for you. These are busy people, and they are often barely able to keep up with the stuff that falls into their official scope of work, so perhaps they simply can’t make the time to help you.  On the other hand, saying “no” when you know you can help a patient is probably not that easy.  Ask.

3.   Try these on for size, Doc.  It is a good idea to ask doctors what they would do in your shoes.  Once we had a shortlist, I asked my oncologist which clinical trial she would choose, medically speaking (ie: not taking into account geography, financial considerations, etc.) and she told me.  That’s the one we’re pursuing right now.  Many doctors will not be comfortable slipping into your metaphorical shoes, but you know what? Cancer isn’t comfortable.  A good oncologist will at least make an effort.

4.   What’s in it for you?  Many hospitals have clinical trial centres.  The objective at these trial clinics is to populate their studies with suitable patients.  In other words, they aim to match patients to the studies that they have,  and NOT to find the best possible clinical trial for a patient from all available clinical trials. They are only working with the trials that they currently have underway at their own clinic and they will select the trial most suitable for a patient from among those trials. Your job as a patient is to find out if participating in the trial offered will bring any real benefit to you (see Phase Matters, below.)

5.   Phase matters.  Trial Phases are important.  This is what I learned about them:

Phase 1

  • Phase 1 trials are for drugs or combinations of drugs that have had good lab results and are now being tested on humans. 
  • Phase 1 trials are designed to establish the correct and safe dose of the drug(s).  This is done with groups of patients – the early groups get a lower dose, and later groups get a higher dose.  If you get a low dose and it doesn’t affect your cancer you do NOT graduate to a higher dose; you are removed from the study.
  • Phase 1 trials are effective against cancers in ONLY APPROXIMATELY 10-15% of cases. Personally, I don’t like those odds.

Phase 2

  • In Phase 2 the dose has been established and the study is concerned with something called pharmacokinetics – how the drug is absorbed, processed and eliminated.  Basically it’s all about figuring out what the side effects are.
  • If you find a Phase 2 study, it has been effective enough in Phase 1 to graduate to the next level.  Meaning it has worked at least enough to warrant more money being spent on it.

Phase 3

  • Phase 3 studies are the final phase of testing before a drug goes to market.  Essentially, the dose and side effects are established and now it’s about ironing out the kinks before lots of money will spent on marketing the drugs to hospitals as standard treatment. And you just know they don’t spend money on stuff unless it’s going to work for a lot of people.
  • Phase 3 studies often involve multiple lines of treatment, meaning they are testing combinations of drugs to see how they work together. From a layman’s point of view, I like the idea of more drugs.  Just say YES, YES, YES.

6.   Take a number. Unfortunately it can take several weeks between identifying and beginning a clinical trial.  In general, 4 weeks must have elapsed since your last treatment and you must meet a litany of study-specific criteria.  You must also provide bloodwork, and other tests like CT scans, ECGs, MUGAs, etc.  The study will also want to access your records and archival tissues.  The good news? You can apply to multiple clinical trials at once, so that if one gets held up you at least have the option of beginning another. But cross-reference the eligibility requirements carefully (especially for specific drugs) to ensure that participation in any one study will not make you ineligible for another study.

7.   Everyone wants a piece of you.  If you apply to multiple studies simultaneously be aware that they may all try to access your archival tumour slides at the same time. These are samples of your disease cells that the hospital preserved at the time of biopsy and/or surgery – and your samples may be limited.  You must be sure that you communicate to the archivist which study gets priority access, otherwise the one you really want to get into may be bumped by your back-up clinical trial just because the latter got there first.

8.   Help, I need somebody.  The research, the meetings, the phone calls, the follow-up, logistics, financial considerations, psychological implications, and oh by the way you’re supposed to be resting and rebuilding your immune system…  It’s so frigging overwhelming.  You can’t do it alone, and you don’t have to.  I don’t care what your circumstances are, You. Are. Not. Alone.  For one thing, if you’re reading this you have access to the internet, which means access to other people.  Help is out there.  Just contact your hospital social worker, or the Canadian Cancer Society, or one of your local cancer support agencies. They can help you find someone to advocate for you, support you, talk you through it – whatever you need.  The nice thing about being hit with the cancer stick (the “nice” thing? did I just write that??) is that there is a LOT of support out there for us. 

9.   Smashing things works. I never knew how good it felt to get mad and break things, especially when it feels like there is literally nothing else you can do. I highly recommend you get yourself a Rage Box.   

 

I’m sure I’ve missed some things but that’s all for now.  This is the part where the resting and the rebuilding of the immune system happens: I’m taking a nap.

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5 Comments

Filed under Living with Breast Cancer

5 responses to “Finding Clinical Trials: Tips For Navigating The Void

  1. Jodi Lastman

    You’ve figured all that out in about 2 weeks? You have given many people a valuable guide book to navigate a scary and uncharted part of dealing with cancer. Aren’t you amazing!

    I think I see your next career calling–the world needs a clinical trial consulting business staffed by experts. Maybe litigation is the issue. If not, it seems ripe for the taking.

    It sounds like you’ve already got a full time job figuring all of this stuff out on your own (oh yeah, and being a mom, blogger, etc.). Imagine being a single parent. How the hell could anyone do it. Blows my mind.

    Kisses.

  2. Lisa B.

    I have no words. At the situation but mostly at your resilience. As Kit said to Viv, “Take care of you.”

  3. Lucy K.

    You inspire me, teach me, and amaze me. I cry with you, applaud you, pray for you, cheer you and love you. You and your personal team are the best you can be/have. Leanne, you will be a winner here – I just feel it. Thank you for all you give us.
    Feel the hugs,
    Lucy K.

  4. Jen Thomson

    We went to Huron at the same time…think we were in Phil of Law together – a mutual friend let me know about your blog. Just reading a few entries – you astound me. You are nothing short of an inspiration. If your daughter has even an ounce of the strength and grace you possess, she will be one remarkable woman – what a gift.
    I thought I’d had bad days – I now realize I don’t know a bad day! Thanks for that. Keep that fight in you.
    Will keep reading and sending you positive thoughts!
    Jen

  5. Leanne

    JODI – thanks (once again) for the encouraging words, but looks like someone beat me to my next job (which is a relief because I still have a headache from the experience of learning all that in such a short time!) I have just heard about a patient advocate service that helps people navigate this process. So relieved to hear that something exists to make it less daunting and confusing — am waiting for more info and then will post details.

    JEN (Huron! That’s going back!!) LUCY and LISA — Just so you know these kinds of supportive (and hugely complemeting) comments are so incredibly nice to read — I so often feel like I am totally baring my soul and after a while it can make a girl feel rather exposed. When you say such warm and positive things it just makes me want to keep on going, because I actually feel less exposed and more connected.

    Also, LISA I don’t know who Kit and Viv are (please tell me!!!) although they could be the two drag queens who once taught me how to dance in stillettos? Just sounds like something that they would say while wiping a Viva Glam lipstick kiss-mark off my cheek with a giant but fabulously manicured thumb.

    Goodnight ladies, and thanks to all of you,
    l.

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