25. Being a “Change Agent” with Clinical Trials

Lori Marx-Rubiner is a social worker, writer and breast cancer coach. On the national level, she is involved in advocacy and serves on peer review for the Department of Defense Breast Cancer Research Project (a Congressionally Directed Medical Research Program). Locally she coaches women through their diagnoses and into treatment, and has led in-treatment support groups. She is particularly interested in working with young mothers who are parenting through cancer. Lori was first diagnosed with lobular carcinoma in 2002, at the age of 35, and nearly ten years later was diagnosed with metastatic breast cancer. She writes and speaks on issues from “The Pinking of America” and the marketing of breast cancer, to the importance of science-based evidence in treatment decision-making, to what we can each do to make a difference. She lives in Los Angeles with her amazing support team: her husband John and her 13-year-old son Zach. Lori’s blog can be found at www.regrounding.wordpress.com.

How does working the night shift impact your breast cancer risk?

Would the early detection of DNA damage help determine future breast cancer risk?

Can breast milk be screened for breast cancer, or to determine breast cancer risk?

Does one’s breath contain biomarkers for the early detection of ovarian cancer?

Might acupuncture improve the sleep of breast cancer survivors?

Clinical trials. This is how we will find the cure to breast cancer. However, the only way to complete and assess the outcomes and potential of new therapy is to conduct and complete a clinical trial. And as frustrated as we can be with the pace of trials, and finding a cure, we hold the key — we can be the change agent….

There are a number of reasons that researchers struggle to enroll sufficient participants in their trials, but until they do, the research can’t move forward. However, there are many preconceived notions about what it means to participate in a trial, and many of them hamper participation. They are mostly about how the trial participant is protected.

How is the patient protected?

  • Treatment Protocols – Many people fear that in a trial they will be put into a “placebo” group or a “treatment” group. When it comes to breast cancer research, potential treatments are evaluated as compared to the existing standard of care. In other words, you will either receive they “usual” treatment or the “new” treatment.
  • Informed consent – Before participating in a trial all of the key information about the study is disclosed. The purpose, duration, requirements, and potential risks and benefits are explained. There are also opportunities to ask questions of the research team. If a patient changes her mind about participation at any point, even after the trial has begun, she may withdraw. Period.
  • Ethics Review – Every trial in the United States is overseen by an Institutional Review Board (IRB). This board is charged with the responsiblity for minimizing risks to and protecting participants, as well as the maintenance of ethical standards. Research is subject to ongoing review by the IRB.
  • Worse Than Standard Care? Many patients fear that clinical trials will only make things worse. The truth is, anything is possible. However we are typically comparing the “current” treatment with ones that researchers believe could be better. And nothing, nothing, nothing arrives in human trials without being thoroughly tested in the lab first.

The subject of trials has been on my mind for some time, but is particularly poignant just now. Over the next two weeks I will conclude a process of peer review for breast cancer research. Along with a team of about 20 individuals, both scientists and consumers, we will have reviewed nearly 50 studies. As a peer reviewer my primary job is to evaluate the impact and innovation of these studies from the perspective of the breast cancer community – patients, survivors and caregivers. Tonight I submitted the last of my eight critiques, and my head is still spinning. With the AMAZING support provided by a team of people, I got it all done. How well I understood the content remains to be seen, but the very idea that *I* could be involved, on any level, to discovering a cure is AWEsome.

Here’s the good news…you can get involved too!

1. Number one, most exciting thing you can do: JOIN THE ARMY! If you haven’t already heard, Dr. Susan Love & the Avon Foundation have teamed up to create Army of Women. This is an incredible opportunity, especially for our supporters who have not been diagnosed with breast cancer, to get involved!

2. To learn more about clinical trials in America, check out US Clinical Trials.

3. For more on breast cancer trials in particular, check out Breast Cancer Trials.

And most of all, know that your participation in clinical trials can lead us to a cure!

Post Script: I failed to mention that not all trials are for new or newly-applied medications, either. For example, I just received a blood sample collection kit for a trial looking at heredity and cancer. My involvement in the trial: a few vials of blood given at my next doctor appointment and a survey about my family…so simple!

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2 comments to 25. Being a “Change Agent” with Clinical Trials

  • Lori,

    Thank you for such an informative and powerful essay. You really clarified so much about clinical trials. I admire your perseverence in educating others.

  • Clinical trials are critical to finding a cure. May I offer one additional word of advice, from someone who has participated in more than one clinical trial herself?

    Know and understand what phase trial you will participate in. Stage I trials, for example, test potential toxicity of a new drug – and that means you may be given a large dose that researchers do not know is safe. Understand what this means for you and how it fits into your care.

    Other than that, I’m all for research and clinical trials and intend to keep volunteering!

    Susan

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* GAYLE IN THE MEDIA *

"Seeing clearly through the pink haze" Toronto Sun

*Sad face*: Being happy does not help you live longer" New Scientist

How should we address breast cancer when norms continually change? The Guardian

Your Fun 'No Bra Day' Photos Are Overshadowing Terminal Breast Cancer Patients Broadly

Backlash against “pinkwashing” of breast cancer awareness campaigns BMJ

Breast Cancer to Rise 50 Percent by 2030? Hey, Not So Fast! Health News Review

Breast Cancer: The Flaws in the Cause iafrica.com

How to Make the Biggest Impact With Your Breast Cancer Donations Money

The Very Pink, Very Controversial Business of Breast Cancer Awareness Racked

NFL, Pink Ribbons Not Enough to Win over Women CNN

3 Questions We Need to Answer for Breast Cancer Awareness Month Chronicle of Philanthropy

The problem with National Breast Cancer Awareness Month Women's Health Magazine

Pink Ribbon Envy: Living with an Uncool Cancer The Nib

A Year After Bombings, Some Say 'Boston Strong' Has Gone Overboard NPR, All Things Considered

Canadian Mammogram Study KCRW, NPR Affiliate

Time to Debunk the Mammography Myth CNN

Breast Cancer: Awareness, Activism & Pinkwashing NPR Charlotte

Buying Pink Al Jazeera's The Stream Watch »

The Pink Backlash Orlando Sentinel

Why Jolie's Test Costs So Much CNN

Preventative Mastectomies: Disease and Deception BlogTalkRadio

Angelina Jolie and the 'Breast Cancer Gene' KCRW

Our Feel-Good War on Breast Cancer The New York Times Magazine.

The Story Behind the Pink Ribbon Campaign Sisters Talk Radio

WISH Interview Women's International Summit for Health

Making Cancer About The Patient, Not The Body Part CBS Pittsburgh

Sexy breast cancer campaigns anger many patients USA Today

The perils of pink The Daily

Komen pink campaign creates breast-cancer blues for some Dallas Morning News

A yellow flag for the NFL's pink New York Daily

Gayle Sulik named #7 in SharecareNow’s Top 10 Online Influencers in Breast Cancer

Breast cancer cancer causes so easily derailed Philly Inquirer

Komen Charity Under Microscope for Funding, Science Reuters

The Fight Against Cancer - And Abortion? Salon.com

Susan G. Komen For the Cure defunds Planned Parenthood. In Deep with Angie Coiro

Amid Breast Cancer Month, Is there Pink Fatigue? NPR's All Things Considered

How is Breast Cancer Culture Undermining Women's Health? America’s Radio News Network

Pink Ribbon Culture and Breast Cancer The Kojo Nnamdi Show

The Big Business of Breast Cancer
Marie Claire

Does Breast Cancer Awareness Month Crowd Out Other Diseases? Slate

Pink Inc. Has Many Starting to See Red The Sacramento Bee

Get Your Pink Off Ottawa Citizen

Komen Pink Ribbons Raise Green and Questions USA Today

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