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Cancer news|Research
update 2002-2003
Judy Knapp, Ph.D., MSW, gynecologic social worker at the
University of Pittsburgh Cancer Institute and EyesOnThePrize.org board
member, summarizes important research findings in gynecologic oncology.
2004 
2001
May 2003: Health Insurance
Portability and Accountability Act (HIPAA) and You
January 2003: Testing
a New Vaccine for The Prevention of Human Papillomavirus 16 Infection
in Women
March 2002:
Ovarian Cancer Survival and Genetic Mutations
February 2002:
Neuropsychological Functioning Of Long-Term Cancer Survivors After Chemotherapy
January 2002: Use of the
Internet by oncology patients in Canada and their physicians
Go to 2001 Research Update archive
 Health
Insurance Portability and Accountability Act (HIPAA) and You
New U.S. federal legislation that went into effect on April 14 will
be changing some things about both healthcare delivery and medical
research in the United States.
The law is called Health Insurance Portability and Accountability Act,
or HIPAA. There are two patient-oriented provisions of HIPAA – insurance
portability, which protects a person from losing medical insurance
coverage when switching from one plan to another, even with a pre-existing
health condition; and privacy, requiring healthcare providers to develop
ways of keeping each person’s health information secure. Perhaps
you have already encountered HIPAA on a routine visit to your doctor
or hospital. You may have been given a Notice of Privacy Policies or
asked to sign a new form.
What does HIPAA have to do with medical research? Generally, your
protected health information (PHI) will not be available to researchers
without
your consent. Staff and physicians who are involved in your clinical
care will still have access to your PHI and may approach you directly
if you are eligible for a clinical research trial. For the most part,
all other researchers will require your written authorization to
look at your PHI, unless identifying data have been removed. If you
decide
to participate in a specific study, you will sign documents that
both give your informed consent to the research and outline the planned
use of your PHI. Your rights and responsibilities, as well as those
of the institution, will be clearly outlined.
Alternatively, you may be asked to participate in a research registry.
Rather than being specific to a particular research study, this is
a more general approach to obtaining patient authorization. A research
registry is a database of information about individuals who agree
to let their past or present medical information be used by researchers,
and to be asked in the future about study participation. As with
all
healthcare decisions, the decision to be in a study or a research
registry should be carefully considered and fully understood. HIPAA
provides
not only information, but also protection to patients who may also
become research subjects.
Testing
a New Vaccine for The Prevention of Human Papillomavirus 16 Infection
in Women
Although there are over 30 types of human papillomavirus (HPV) that
have been found in humans, HPV 16 is the one that is most often associated
with the development of cervical, anal and other genital cancers in
women.
Evidence of HPV 16 has been found in half of cervix cancer tumors,
as well as high-grade cervical intraepithelial neoplasia (CIN), which
can
develop into overt cancer. The infection rate for this virus is about
20% in the adult population; as such, HPV 16 represents a significant
health risk.
A paper in the November 21, 2002 issue of The New England Journal of
Medicine by Dr. Laura Koutsky and her associates is the first evidence
of the effectiveness of a vaccine to protect women from HPV 16 infection.
In this study, 1533 women (from a study group of 2392) met the criteria
for primary statistical analysis of the data. These women received
either placebo (inactive) or active vaccine 3 times over a six month
period.
The vaccine was administered as an intramuscular injection. Persistent
infection with HPV 16 was found in 3.8 per 100 woman-years at risk
in the placebo group and 0 per 100 woman-years at risk in the active
treatment
group. Additionally, there were no new cases of HPV 16 infection or
HPV 16-related CIN among the women who received active vaccine, while
there
were 41 new cases of infection and 9 cases of CIN among the untreated
group.
The investigators have called for additional research into the development
of a vaccine for multiple types of HPV to broaden the potential for
protection. The goal is to be able to vaccinate young women as they approach
initiation
of sexual activity to reduce their risk of cervical and related cancers.
This vaccine, however, is not believed to be of benefit to women who
are already being treated for these cancers.
March 2002: Ovarian Cancer Survival and Genetic Mutations
A group of researchers in Israel has examined the question of whether
or not having a genetic mutation effects prognosis in women with epithelial
ovarian cancer. These investigators, led by Dr. Yehuda Ben David, used
blood or tissue samples from 896 ovarian cancer patients. Of this number,
234 or 26% were positive for BRCA1 or BRCA2 gene mutations. Comparisons
were conducted on both rates of survival and duration of survival between
mutation carriers and noncarriers. Survival rates at three years from
diagnosis was significantly better for women in Stage III and Stage
IV with the mutation than for those without the mutation,
at 60.3% and 44.5% respectively. Also duration of overall survival was
longer for the mutation-positive with advanced disease at diagnosis.
In these women, the median survival was 51.2 months, as opposed to 33.1
months for mutation-negative women.
These findings were not affected by age, stage, or family history,
although these are all factors that can influence prognosis. It is not
yet known if ovarian cancer is less aggressive when it arises due to
a gene mutation. Another possibility is that treatment is, for some
reason, more effective in these cases. This research report was published
in the January 15, 2002 issue of Journal of Clinical Oncology.
February 2002: Neuropsychological Functioning Of Long-Term Cancer Survivors
After Chemotherapy
According to research published in the January 15, 2002 issue of Journal
of Clinical Oncology, long-term survivors of breast cancer and lymphoma
who received standard-dose systemic chemotherapy scored significantly
lower on certain neuropsychological measures than did survivors who
only had surgery or local radiation therapy. Dr. Tim Ahles and his associates
at the Department of Psychiatry at Dartmouth-Hitchcock Medical Center
in New Hampshire compared 71 postchemotherapy patients with 57 patients
of similar age and diagnosis who did not receive any chemotherapy as
part of their cancer care. The average period of time from their initial
diagnosis was over nine years; all subjects had no evidence of disease
at the time of the testing.
According to the authors, other research has suggested that memory
deficits and problems with concentration are found in patients who underwent
chemotherapy up to two years prior to testing. This study was designed
to look at cognitive functioning at a time period more distant from
the chemotherapy treatment.
Tests of neuropsychological functioning included verbal memory, spatial
ability, visual memory, verbal ability, psychomotor functioning, attention,
and reaction time. Measures of fatigue, anxiety and depression were
also given to the research participants. However, these psychological
factors did not appear to be related to cognitive functioning in any
of the groups. The most striking finding from the study was the significant
difference in verbal memory and psychomotor functioning between patients
who received chemotherapy and those who did not. Because nearly 10 years
had elapsed, on average, between the time of diagnosis and testing,
the authors suggest that deficits associated with chemotherapy appear
to be persistent. They also conclude that further research into this
question is needed. These studies might focus on understanding the neurological
mechanisms that may produce these changes and possible interventions
to minimize problems for chemotherapy patients in the future.
January 2002: Use of the Internet by oncology patients in Canada and their
physicians
Results of a descriptive survey of Internet use by patients with cancer
and their physicians were published in the December 2001 issue of Journal
of Clinical Oncology. Prior to this time, very little scientific investigation
into a Web-based approach to information-seeking had been conducted.
Two researchers at a university hospital in Toronto developed a short
questionnaire to explore patients’ information-seeking behaviors
and attitudes, ways of coping with their illness, and relationship with
their physician. Responses from 191 surveys were used in the analysis
of the data. Another questionnaire for physicians was mailed out and
received back from 420 respondents.
Of the patients who responded to the questionnaire, 85% were Caucasian,
76% listed English as their first language, 40% had completed college,
64% were female, and 58% had Internet access at home. Over 86% reported
that they wanted as much information as they could get about their diagnosis
and treatment, yet nearly 54% did not rate the information they received
from physicians and other healthcare professionals as adequate. The
Internet was the most frequent source of additional information for
the 71% of respondents who acknowledged looking beyond their healthcare
team. Specific treatment information was the category most frequently
used by patients. Over one-third of the patients made treatment decisions
based in part on information obtained from the Internet. Interestingly,
factors such as gender, age, educational level and socioeconomic status
were not related to information searching.
Physicians who answered the survey, primarily medical and radiation
oncologists, did not think that trust in the doctor-patient relationship
was threatened by patients’ decision to seek additional information.
Only 16% indicated that they were ‘mildly irritated’ by this,
while 38% were supportive and 45% were neutral. Of the physicians who
indicated that they also looked on the Internet for available medical
information, the most common reason cited (52%) was to be prepared for
patients’ questions.
As the researchers recognize, this study was conducted with a convenience
sample of patients who were willing to complete the questionnaire. For
this reason, there is a potential bias towards those who were healthier
and more interested in the topic. However, the study represents the
beginning step toward understanding a significant phenomenon in a country
with nationalized health care delivery, as well as a foundation upon
which to build more sophisticated research.
Go to 2001 Research Update archive
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