Part 2: How we enroll patients into clinical trials

You may come to find out about a clinical trial when:

• Your physician refers you for a specific clinical trail
• Your nurse may ask a research coordinator to locate a trial for you
• You (the patient) may ask if there are any research studies available

Once a trial has been identified the study coordinator (research nurse) reviews your chart and the available protocols to determine if you qualify.

If you qualify the study coordinator will provide you with an “Informed Consent Form” to review. We encourage our patients to take a few days to review and share the information with your spouse, significant others and family.

After review you’ll be asked to meet with the physician and research coordinator. You’ll spend this time discussing the consent form, treatment plan, expectations, risks and benefits. Don’t worry, you’ll have plenty of time to ask questions. If, at the end of this conversation you’re still interested you will begin the consenting process.

Consenting Process
The consent process is legally required by the FDA and other governing authorities like the Institutional Review Board (IRB). You (the patient), the physician and the research nurse must all sign and date the same consent form.

• You are given a copy of the signed consent form
• A copy is stored in your patient chart (along with the protocol details)
• The original is stored in research

The consent process should never feel rushed—you as the patient should receive the information you need about the study. The process must:

• Give you enough time to consider all your options
• Respond to all of your questions
• Ensure you understand all the information
• Continue to provide all the information you require

Be sure to check back Friday when we post, "Part 3: I gave consent, now what?"

For more information:

• Part 1: Why we believe in research studies
• A guide to understanding informed consent

Part 1: Why we believe in research studies

At Providence Regional Cancer System we participate in clinical research for many reasons. Clinical trials are vital in finding and establishing improved, less toxic ways to treat cancer. It is our hope that participation in a clinical trial will improve our patient’s quality of life and/or extend life.

We are always striving to:

• Help find an improved cancer treatment with better outcomes for our patients
• Help gather statistics for future generations who will be looking for better treatment
• Help our physicians stay on the forefront of new treatment options
• And of course, the ultimate goal, help discover a cure for cancer

You may or may not have followed the journey of the late Elizabeth Edwards, attorney, best-selling author and health care activist, she lost her fight with metastatic breast cancer at the age of 61.

Regardless of how you feel about her as a person she was a champion for medical research, participating in numerous clinical trials, speaking of the women who came before her,

"I knew I could not repay those women -- most much braver than I, many of whom had taken a chance with their own treatment in order to help find the best treatment for all of us -- except by helping the women who would come after me.”

The decision to participate in a clinical trial is a personal one. That’s why; throughout the whole process we always put you, the patient, first. If at any time you want to remove yourself you can. Doing so will never affect the care you receive from your treatment team.

Be sure to check back on Wednesday when we post, "Part 2: How a patient becomes part of a clinical trial"

Book Excerpt: Saving Graces: Finding solace and strength from friends and strangers by Elizabeth Edwards

8 questions to ask before every test your doctor runs

Sometimes it seems like the tests never end.

When your doctor tells you that you need another test it’s important for you to understand why. Next time you hear, “We need to run another test,” ask these eight questions, the answers should help you generate useful dialogue between you and your doctor. 

1. What is the purpose of this particular study or test?
2. What do the results mean?
3. How will the results influence my treatment?
4. Will I need any more tests or studies?
5. How frequently will I need a test or study done?
6. What would be the possible risks if I decide to limit the number of tests I have?
7. The potential benefits?
8. Are there any limitations or possible errors with this test or study?

To illustrate what this dialogue may sound like between you and your doctor I’ve provided two different scenarios. In the first scenario I have just told the patient that I have found a lump in her breast. The test I would like to run is a mammogram.

1. What is the purpose of this particular study or test?
   As your providers we need to further evaluate if what I found is a mass in your breast.
2. What do the results mean?
   Most of the time a mammogram will confirm a finding of a mass or lump.
3. How will the results influence my treatment?
   If we do find the mammogram is abnormal we will need to conduct a biopsy.
4. Will I need any more tests or studies?
   If the mammogram is inconclusive you may need to have more imaging/pictures taken through repeat mammogram or an ultrasound or MRI of your breast.
5. How frequently will I need a test or study done?
   We may need to repeat the mammogram in a few weeks or few months depending on the severity of the situation.
6. What would be the possible risks if I decide to limit the number of tests I have?
   If you decide to limit the number of tests you could potentially delay/miss diagnosis and treatment.
7. The potential benefits?
   Any early diagnosis typically means a better chance for a cure.
8. Are there any limitations or possible errors with this test or study?
   A small percentage of patients/cases could be missed despite extensive testing because there is always a limitation to certain tests/technology. The more complete the evaluation, the better chance to have the right diagnosis and prompt treatment.

If that same patient gets an “abnormal mammogram” I would then recommend to the patient that we biopsy the tissue.

1. What is the purpose of this particular study or test?
   A biopsy will tell us if the affected region is cancer or not cancer.
2. What do the results mean?
   The results will tell us whether the affected region is benign, suspicious, or cancer.
3. How will the results influence my treatment?
   In most cases a benign finding would need no more treatment; a suspicious finding would need either a repeat biopsy or close monitoring; a cancer or malignant finding would possibly need surgery. Sometimes, chemotherapy before surgery could also be considered depended on the size and location of the lump.
4. Will I need any more tests or studies?
   If there is an abnormal lymph node found either by physical exam or mammogram, further CT scan would also be considered.
5. How frequently will I need a test or study done?
   If we decide to repeat the biopsy due to a suspicious finding we would do so right away. If we decide to closely monitor you we will most likely recommend a mammogram or MRI in 1~3months or 3~6months pending level of suspicion.
6. What would be the possible risks if I decide to limit the number of tests I have?
   If you decide to limit the number of tests you could potentially delay/miss diagnosis and treatment.
7. The potential benefits?
   We will be able to initiate appropriate treatment in a timely fashion and best treat the disease which means a better chance for early diagnosis and cure.
8. Are there any limitations or possible errors with this test or study?
   At times a biopsy may not provide an adequate sample amount meaning we can miss the real diagnosis.

Remember, as the patient your understanding is the most important thing. If you don’t like the way a question was answered or you want more information, ask it again, as many times as you need to.

Editors Note: The examples provided in this post are fictional and do not reference an actual patient. If you find yourself undergoing the same tests be sure to ask your doctor about your specific situation.

A 2011 resolution: Exercise more to help your cancer treatment

"Exercise, Me, are you joking?" This is a comment that I have heard many times over by those in treatment who simply cannot imagine another part to their cancer treatment. As a lymphedema therapist at Providence St.Peter Hospital Outpatient Lymphedema clinic I have had the privilege in my 6 years specializing to work closely with numerous cancer patients on their treatment journey.

Exercise is often viewed as a double sided coin; on one side is the desire to work out and the other is the fear of the unknown and how exercise will effect someone going through cancer treatment. In fact, The American Cancer Society advises that individuals going through cancer treatment, with approval from your doctor, benefit from moderate activity 3-5 times a week. Moderate activity is defined as the equivalent to a brisk walk OR performing a task where you can still carry on a conversation.

Exercise has many positive side effects in cancer patients such as:

• Decreasing fatigue, nausea, anemia
• Improving mental clarity
• Promoting a sense of well being
• Reducing stress
• Reduce the deconditioning that can come with decreased activity

If you have found yourself feeling "tight" after surgery or radiation or "drained" from chemotherapy simple stretching can be a wonderful tool to helping you feel "more like you."

Exercise does not have to be a structured program! Just getting up and moving will help and feel good. Simple housework and your daily routine may be enough. Did you know vacuuming or mopping burns ~150 calories an hour? Calculate how much you're already doing with The American Cancer Society's exercise calculator.

Your body will tell you if you’ve done too much or are where you should be. Again, be sure to talk with your doctor and consider keeping an exercise journal. That way you can track your progress and check in at your appointments to make sure you're on the right track for you.

You might also like:

• What is yoga and how can it help me?
• You don't have to put up with cancer related fatigue
• Just because it's natural doesn't mean it's safe

Cancer: What's in a diagnosis?

When you or someone you love receives a diagnosis of cancer you find out a few things.

First, the type of cancer. These terms you are probably familiar with: breast cancer, cervical cancer, colorectal cancer, lung cancer … the list goes on. In fact, The National Cancer Society reports there are around 200 types of cancer.

The next modifier you receive will most likely be a number, I, II, III or IV. The stage of cancer reflects how far the cancer has spread through your body.

• Stage I indicates that the cancer is small and still contained within the organ of origination. 
• Stage II indicates a larger size than stage I but the cancer is still contained in the organ of origination. In some cases the cancer may have spread to the lymph nodes closest to the affected organ.
• Stage III indicates a larger cancer in which the spread has surpassed the organ of origination and is now affecting the surrounding tissues and the nearby lymph nodes.
• Stage IV indicates that the cancer has spread from the organ of origination into another body organ.

Your physician may also use terms like, “localized,” “regional,” and “distant”. These are simply a different way of categorizing the stage of cancer. A good rule of thumb is, the lower the stage the more localized the cancer.

With every cancer diagnosis you will also receive a treatment plan where you and your physician will talk in-depth about the benefits and risks of all your options and inevitably your chance of beating cancer. While we say that the lower stage the higher an individual’s survival chances the reality is that we are continually making strides in the treatment of late stage cancer.

In all cancer diagnoses it’s important that you work with your entire care team to develop an integrated approach to treatment, combining the latest advances in science with healthy life options.

You might also like:

• Lynns #1 lesson: There are no stupid questions
• Who is a cancer survivor? What's in a name?
• Integrative care basic and what others are saying