Monday, August 15, 2016

NEED YOUR HELP TO DEVELOP A RESEARCH STUDY

There is a debate and the debate will continue until someone steps up and tries to provide definitive answers by way of a randomized clinical trial.

I have been discussing this study alongside many other advocates with researchers who are trying to help answer a few questions.

Simply stated, indeed somewhat oversimplified:

If a sentinel node biopsy finds 1-3 positive nodes and the tumor is tested and is shown to have a very low risk of recurrence, is it necessary to administer radiation? If a frozen section during surgery shows a couple of positive lymph nodes sent to pathology for immediate testing, is it necessary to remove all of the lymph nodes as part of that surgical procedure?

That's at the heart of the questions the researchers would like to answer. As with most treatments, decisions are made or they should be made, based upon the evidence. What are the possible side effects? Am I actually deriving a benefit by doing this or am I potentially causing unnecessary harm because it can be shown to have no benefit to radiate or to do further surgery?

It's a complicated study and it's a bit complicated to frame the questions in ways that will be relevant to patients. The thing is this: it's a fairly sure bet, many women do benefit from radiation therapy and many do not. Some need all of their lymph nodes removed, or maybe not. Perhaps removal of the lymph nodes is doing absolutely nothing to stop metastasis from occurring but we do know it is putting people at risk of lymphedema which is debilitating. To most of us, it's just a word. A possible side effect. To those living with compression sleeves, ask them to share what it's like to live with this.



That's the back story. This is where YOU come in. You are **not** participating in any study. You ARE giving feedback so the researchers can determine how to design a trial that will matter to newly diagnosed patients. They want to learn about our feelings about the whole lymph node thing to help frame a possible study.

If you have been diagnosed with invasive breast cancer, regardless of whether or not you had lymph node involvement and if you were diagnosed at Stage 1, 2 or 3, and you were diagnosed any time prior to September 15, 2015, take the survey!

This is an important question. And there isn't agreement in the medical community. Just this month, there were two oppositional viewpoints published in the JAMA Oncology. One group says NO. One group says YES.

The only way to settle this is by doing a clinical trial. There will be many steps before this can happen and we are at the very first step. The information gathering step. It is a testament to the commitment of the researchers involved that before they did anything else, they assembled a group of patients. If they did that, the least I will do is help gather the information.

Compelling information about how this would be done and why it matters must be submitted to the funding agency to see if they will even think this is worthwhile to extend the researchers an invitation to submit a full proposal. There is nothing more compelling than information that may be gleaned from the experience of real patients, not what researchers think real patients think.

So please, take the survey. This way, the researchers might analyze our thoughts to make sure the letter of intent is compelling and truly reflects the needs and concerns that are most important to those who really matter. Patients.

The link to the survey, with the address all written out in case you have to copy and paste can be found at https://redcap.mskcc.org/surveys/?s=NCAKNFFW9L. The survey will not take more than 5 minutes (maybe 10 if you type really really slowly).

This is important. I'm asking for your help. Help brainstorm via the survey. Please share the link in as many places as you can. If you are in a Facebook group, ask the admins if you can post a link. Hit twitter or whatever other social media channels you feel might be helpful.

Competition for funding is fierce and it is exceptionally difficult to be awarded grant money. As an aside, I know some will say this is not nearly as urgent as helping promote research to stop deaths from metastatic disease. I know that nothing is more urgent than death and I will (and do) work in those circles too. Please don't look upon this request as me being insensitive to those needs. I am acutely aware and working diligently to see that appropriate research is funded by working beside METAvivor for their award cycle.  My world is multi-tentacled and just like the answers we seek to take meaningful steps to begin to resolve the the many problems we call cancer are complex and tangled, so am I.

Today, it's about 5 minutes of your time.

I'd love to see just 100 people give their input. And on that note, I'm offering advance thanks!


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3 comments:

  1. Hi Anne Marie, I just completed the survey.

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  2. Perfect survey for me, thank you many times over.

    I had a sentinel during my mastectomies. Two nodes were positive, so my surgeon did the axillary. I'd made clear from the first appointment that "you can't have my nodes," but she also knew I was adamant about the complete removal of potentially cancerous tissue. She also knew that I did not want any more surgery (or rather, anesthesia), so she continued.

    I will always love her for understanding me so well, and I'm so very grateful she was the surgeon to whom I was assigned (even though she was not the surgeon to whom I was referred).

    I had to fight for radiation, because at the time, it was not the standard for mastectomy patients with 1-3 nodes. I got it, though, because the new studies showed a benefit, and my RO was on top of things. If it were up to my MO, I suspect I'd have recurred early on.

    Five years out, and no sign of cancer. I know it can come back any old time it wants to, but I believe that the radiation and axillary dissection went a long way to head that off.

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