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Patients Against Lymphoma

 

Clinical Trials >  How to Inquire about Clinical Trials

Last update: 12/09/2014

Topics:

Asking your Treating Physician | Contacting an Investigator Directly | Consulting an Independent Expert
Consult Checklist | Questions to Ask | Resources

How to Consider and Inquire about Clinical Trials

A Guide for Patients and Caregivers

Is a clinical trial a good choice for you?

Start by reviewing the following guidelines - an overview to help you to decide if there is a rationale for considering a trial and how to discuss the rationale with your medical doctors. 

7 Reasons to Consider Trials based on our clinical circumstances 
 

How to locate trials on your own (optional)

We assume people will look for trials for different reasons and in different ways. So we have developed 3 ways to find trials:

1  Following a favorable published report by searching for open trials By Agent

2  When first diagnosis or relapsed, by searching for trials By Type of Lymphoma AND Treatment Status

By reviewing PAL's Picks: Trials of Interest
 

These are studies that look promising to our group and by our scientific advisors based on recent reports. The trials are grouped by type of lymphoma.  We provide this list in order to assist in the conversation about trials with your oncologist or when you consult an expert for a second opinion.

If you have found a study of interest:
 

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Take note of the eligibility criteria, the location of the study, and 
the contact information.

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Take note of the goal of the study.
 
For example, is it a dose-finding (phase I) study,
or a phase II with good preliminary evidence,
or a phase III comparing the study protocol to the the standard of care?

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Print the protocol so that you have something to show the medical providers that you consult.

You might ask for feedback from the support community as a starting point:
bullet If the protocols seem a good fit, feel free to discuss one or more of the many peer-based support forums

For example, we can help to explain terminology, help you to locate safety and efficacy reports, or point you to papers describing mechanisms of action.

* Most importantly:

bullet Seek and rely on the guidance of medical professionals, who have training and first-hand information
about your diagnosis and clinical circumstances.


Ask your Treating Physician:

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Review the Consult Checklist below.

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Doctor: "What is the standard of care for my diagnosis and clinical circumstance?

and do you think this (the printed protocol) or some other study is appropriate?"

OR

Contact the Study Investigator Directly:

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Review the Consult Checklist below.

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Call or email the investigator using the contact information on the protocol.

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Ask the investigator to contact your doctor on your behalf to discuss the protocol.

AND / OR

Consult an Independent Expert:

This is the PREFERRED METHOD because independent experts will have first-hand information about your clinical circumstance, and will also be aware of the important clinical trials, and which are most likely to be appropriate for you - based on your clinical details and the most appropriate goal of therapy. 

By "independent" we mean an expert who will not administer therapy, and therefore has no (unconscious) financial interest in his or her recommendation, and will not limit the conversation to studies provided at their center.  (See also Conflict of Interest in Treatment Decisions PAL)

bullet

Review the Consult Checklist below.

bullet

Doctor: "What is the standard of care for my diagnosis and clinical circumstance?

and do you think this (the printed protocol) or some other study is appropriate?"


Clinical Trials - Consult Checklist:

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Bring a loved one with you to the consult. 
Involving a trusted loved one, even if just to listen, is proven to improve the quality of the consult.

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Provide a copy of your questions in writing ahead of the meeting.
Be concise and indicate which questions are most important to you.

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Questions to ask to include clinical trials in the conversation:

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What is the goal of treatment when treatment is needed?

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What regular treatment is most appropriate to my clinical circumstance and diagnosis ...

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What clinical trials might I consider at this center or elsewhere?

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How is the study different from the regular approach?

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Am I eligible for the study? 

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Will my insurance cover associated costs? 
 
The Patient Protection and Affordability Act (ACA) will help to this problem when
fully implemented - but only if the center is within the network covered
by your insurance (a gap in the ACA).

The sponsor is obligated to pay for the study drug
and special tests that are not part of regular care.

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Is travel or lodging an obstacle (physically or financially)?  
 
See Travel and Lodging for Treatment

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Do other medical providers that you've consulted agree with the recommendation?

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Have the experts you consult contact your treating physicians in order to
reach a consensus on what treatment protocol is best for you.

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Be sure to ask for the reason (the rationale) for the recommendations
(for or against), particularly if you get different opinions.

bullet Review with your doctor the
7 Reasons to Consider Trials based on our clinical circumstances PDF
 
bullet Go back to your treating oncologist and ask for additional advice -
discuss the pros and cons of what was recommended.

Questions to Ask Your Doctor or Nurse about Trial Participation

After discussion of the goal of the next treatment, we recommend starting the conversation about clinical trials by asking: 

What is the recommended regular treatment when treatment is needed? 
By using the word “regular” we can then transition to the follow up question:

What trials can we also consider now, before the need to treat, or when treatment is needed?
What specialists might I consult nearby to inquire about trials?
 

If so:

bullet

What is the purpose of the study?

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How might I benefit from participating?

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What are the known risks from participating?

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What were the results of other studies of this treatment?

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What other treatments could I receive if I don't take part in the study?

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How do the risks and potential benefits of the study compare with the regular treatment?

With consideration of your specific diagnosis, treatment history, and risk factors.

If I join the study:

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How am I protected from possible adverse events?

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What tests are in the study, and how often are they given?

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Can I decide to stop participating at any time?  (Yes, you can)

And if so, will it affect the care I receive? (No, it will not)

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Will I continue to see my current doctor?

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How will participating effect daily activities? Will I still be able to work or go to school?

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Will I have to be in the hospital?   How many days?

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What are the possible risks or side effects for me?

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Will my insurance cover procedures and tests?

If not, will the drug sponsor cover it?

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Will there be extra costs because of the study?

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How will I be checked after the study, and how often?

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How long will the study last and how long will I be tested?

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Will I be made aware of the results?


Important Points About Side Effects:

Side effects and uncertainty about them are not unique to clinical trials.

Here are important points about side effects that may apply to studies. 

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The study doctors do not know who will or will not have side effects.

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Some side effects may go away soon, some may last a long time, or some may never go away.

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Some side effects may interfere with your ability to have children.

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Some side effects may be serious and may even result in death.

Here are important points about how you and the study doctor can make side effects less of a problem:

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Tell the study doctor if you notice or feel anything different so they can see if you are having a side effect.

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The study doctor may be able to treat some side effects.

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The study doctor may discontinue or adjust the dose of the treatment to try to reduce side effects.

  

Resources

  1. Doctor Visits - A Checklist to Help You Prepare PAL
  2. Benefits Versus Risks Merck
  3. Conflict of Interest in Treatment Decisions: PAL 
  4. Travel for Treatment
  5. When to Consider Clinical Trials?
  6. Cure Magazine: The Treatment Option You May Be Missing http://bit.ly/bItRI7
  7. Things you can do to get your health insurance to cover a clinical trial cancer.gov ... still an issue until 2014, when the Health Care Reform measure kicks in.
  8. When is conflict of interest most likely to become a factor in medical advice?  PAL
  9. ACT: Please Bring Our Survey to Your Next Consult

    to help start the conversation about trials, and
    also to help identify obstacles to clinical trial referrals.
  10. About PAL's Tools to Locate Lymphoma Trials
  11. Patient-to-patient - CT About finding, evaluating, choosing clinical trials
     
 
Disclaimer:  The information on Lymphomation.org is not intended to be a substitute for 
professional medical advice or to replace your relationship with a physician.
For all medical concerns,  you should always consult your doctor. 
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