Clinical trials

[Joan37]

Clinical trials are not a last resort and often times they can be used if appropriate much earlier as an option. Trials specifically for breast cancer can be found at bctrials.org, under the special search engine for metastatic breast cancer trials.

(The website is b c trials dot org, just in case it comes up as something else. The system keeps wanting to change it.)

Test your clinical trial IQ:

1. My participation in a clinical trial is strictly voluntary. T/F (T)

•True

•A clinical trial participant is a volunteer who chooses to take part in a study.

•As a volunteer, you are free to leave the trial at any time and for any reason. By law, your decision to leave a trial will not affect your quality of care.

Prior to entering a trial, you will have the opportunity to learn about the study medications, tests and procedures, and study site visits.

2. My level of care will go down in a clinical trial. T/F (F) •FALSE •Since clinical trials are research studies, participants are carefully monitored by a team of providers. This may involve more visits to the research site or additional tests than if you were on standard therapy.

3. My previous treatment and overall health will influence my ability to participate in a clinical trial. T/F (T) •TRUE •Clinical trials evaluate the safety and effectiveness of an experimental therapy in patients who share a common medical history. •There is a list of criteria that determine whether a patient is eligible for a trial. These criteria include a potential patient’s previous treatment and other health conditions. •For example, if a trial is studying a medication for newly diagnosed metastatic disease, it will only include patients who have never received treatment for metastatic breast cancer.

4. The new approach being tested is always better than the currently approved treatment. T/F (F) •FALSE •Clinical trials are research studies that test new IDEAS for improving the health of people. •You may personally benefit if an experimental treatment is found to be better than the current standard of care. •It’s also possible that a new treatment may not be better than the standard of care. •Or, the researchers may find that only select groups of people benefit from the new treatment, and you may, or may not, be one of those people.

5. I can only join a treatment clinical trial when no other cancer treatment has worked. T/F (F) •FALSE •Clinical trials are available for patients newly diagnosed with metastatic disease as well as those who have received many prior therapies. •There are also clinical trials that looking at ways to alleviate the symptoms of metastatic treatment or improve a patient’s quality of life.

6. I might only get a placebo (sugar pill) instead of chemotherapy in a clinical trial. T/F (F) •FALSE •Treatment is never withheld from patients in a cancer clinical trial. •Patients in cancer treatment trials receive either the standard of care (the best treatment available for their specific cancer), or receive a new treatment being investigated. The latter generally includes both the standard of care + the experimental therapy. •Only in the rare instance where there is no treatment proven to be effective against a certain type of cancer would patients be randomized to a placebo.

7. Ethnic and racial minority groups are underrepresented in clinical trials. T/F (T) •TRUE •It is estimated that less than 5% of adult cancer patients participate in trials. •These include predominantly educated white patients. •Fewer trial participants come from ethnic and racial minorities. •It is important to engage more minorities to participate in trials: oProvide them with equal access to the latest medical knowledge oTo better understand race-based differences in how cancer is experienced and how different populations respond to new therapies oFor example, African-American women have a lower overall incidence of breast cancer than white women, but are more likely to die from the disease.

8. The law requires that doctors and nurses explain all procedures, risks and benefits when offering a clinical trial. T/F (T) •TRUE •This process is called Informed Consent and is mandated in the Research Participant Bill of Rights.

9. Clinical trials have contributed to advances in metastatic breast cancer treatment. T/F (T) •TRUE •Every advance in metastatic breast cancer has been evaluated in a clinical trial. The clinical trial validates that the new therapy is safe and effective for use by the general public.

10. Patients in clinical trials will have their medical records and names published. T/F (F) •FALSE •The identities of patients who participate in clinical trials are never revealed. •Ways of protecting patient identities are documented in a research protocol that is approved by an Institutional Review Board. •When research is published, the results are expressed as the combined results of participants within each research group. •Individual patient names are never listed in the publications.