SSB_Attachment 3_Sample participant newsletter

Supporting Statement B
Attachment 3

Sample Participant Newsletter

A   P u b l i c at i o n   o f  t h e  W o m e n ’ s   H e a lt h   I n i t i at i v e   •   2 0 0 8 - 2 0 0 9

The Latest on WHI

WHI in the Future

to what you are doing now. We will keep
As part of the WHI Extension Study, we
8 Center
you informed about this possibility as we
will continue to collect your health inforInformation
learn more.
mation each year through 2010. This will
include a complete update of the medicaFocus on Findings in WHI
tions and supplements that you provided
A few of the many findings published
several years ago during the original WHI.
about WHI over the past year are sumInformation about the medications you are
marized below. WHI
taking helps researchers learn more about
participants have let
common treatments for chronic diseases and
health outcomes.
This update will be
The data you are providing
included in the annual questionnaire
will continue to impact
packet you receive
women around the world.
next year as a participant in WHI.
us know that they are very
In recognition of the importance of
interested in knowing about
women’s health, the National Institutes
the many findings from WHI, and some
of Health (NIH) are considering the poshave written to us requesting more details
sibility of continuing the Women’s Health
on the findings reported in the newsletter.
Initiative for additional years of follow-up
You can find all of the details on the WHI
beyond 2010. This would involve completparticipant website at www.whi.org,
ing annual mailed questionnaires, similar

INSIDE THIS  ISSUE

he WHI Extension Study is now in the fourth year of data collection, an amazing
accomplishment for the nearly 120,000 women enrolled in the study. As of August 1 The Latest
on WHI
2008, over 350 papers on WHI results have been published in scientific journals,
with dozens more in various stages of preparation. The data you are providing will continue
4 Preventing
to impact women around the world, by giving researchers the information they need to
Falls in the
answer a broad range of questions about women’s health. WHI researchers will continue to
Home
analyze these data for many, many years to come, ensuring that your past and current contributions to the science of women’s health will have a lasting impact well into the future.
6 The Women
of WHI

continued, p. 2

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T H E L AT E S T O N W H I

which has links to the actual publications summarized in the newsletters. If you do not have internet access, your local librarian may be able to help
you obtain copies of WHI articles. When you visit
your library, be sure to take along the name of the
journal, date, and first author of the article you
are interested in reading. This information is listed
with the summaries of findings in current and
past issues of the newsletters. You might also call
your local WHI clinical center, to see if they can
help you locate this information.

2

WHI08-09.indd 2

n Hormone Therapy Increases Frequency

of Abnormal Mammograms and Breast
Biopsies (Archives of Internal Medicine, Feb. 2008)
Rowan T. Chlebowski, M.D., Ph.D., principal
investigator of the Harbor–UCLA WHI Clinical
Center, and other investigators have published
new findings from the WHI Estrogen plus
Progestin (E+P) Hormone Trial. Of the 16,608
women enrolled in the E+P Trial, 8,506 were
randomly assigned to take active study pills
with combined estrogen plus progestin, while
8,102 took inactive placebo pills. Each woman
had a mammogram and breast examination
yearly. Biopsies were performed based on their
physicians’ clinical judgment.
Dr. Chlebowski and his colleagues found that
combined estrogen plus progestin hormone therapy appears to increase the risk that women will
have abnormal mammograms and breast biopsies,

from that of placebo for at least 12 months after
stopping, the investigators reported.
Breast biopsies also were more common
among women taking hormones than among
those taking placebo (10% vs. 6.1%). “Although
breast cancers were significantly increased and
were diagnosed at higher stages in the combined
hormone group, biopsies in that group less frequently diagnosed cancer (14.8% vs. 19.6%),” the
WHI investigators reported.
These findings suggest that mammograms
and breast biopsies may be more difficult to
interpret for women taking hormones, possibly
reducing their ability to diagnose breast cancer.
The investigators recommend that health care providers include this information when they discuss
risks and benefits with women who are thinking
about taking even short-term combined hormone
therapy.

n Health Risks and Benefits 3 Years After

Stopping Randomized Treatment With
Estrogen and Progestin (Journal of the

American Medical Association, March 2008)

The WHI Estrogen plus Progestin (E+P) Hormone Trial was stopped on July 7, 2002 because
results showed that the overall risks exceeded the
benefits of taking Estrogen plus Progestin, with
women taking E+P at higher risk for heart disease,
blood clots, stroke, and breast cancer, but at lower
risk for fracture and colon cancer.
After stopping the study pills in the
E+P trial, WHI continued to collect
Mammograms and breast biopsies
follow-up study data from these particimay be more difficult to interpret for pants to evaluate the effects of stopping
hormone therapy. This summary reports
women taking hormones.
on the health outcomes of E+P trial
participants three years after the study pill
and may decrease the effectiveness of both tests
intervention was stopped (with a mean average of
for detecting breast cancer. During the 5.6 years
2.4 years of follow-up). Follow-up information for
of the E+P trial, mammograms showing abnormal this period was available on 95% of the women.
results were more common among women takThree years after stopping hormone therapy,
ing hormones than among women taking placebo women who had taken study pills with active E+P
(35% vs. 23%). After the hormones were stopped, no longer had an increased risk of cardiovascular
the adverse effect on mammograms decreased
disease (heart disease, stroke, and blood clots)
somewhat, but remained significantly different
compared with women on placebo. The lower

10/26/08 4:47:03 PM

risk of colorectal cancer seen in women who had
taken active E+P disappeared after stopping the
intervention. The benefit for fractures (broken
bones) in women who had taken active E+P also
disappeared after stopping hormone therapy. On
the other hand, the risk of all cancers combined
in women who had used E+P increased after
stopping the intervention compared
to those on placebo. This was due

T H E L AT E S T O N W H I

the National Institutes of Health) has shown that
modest weight loss, exercise, and a low-fat diet
may reduce the onset of diabetes in persons who
are at risk of developing diabetes.
After an average of 8.1 years of follow-up, a
total of 3,342 of the 48,835 WHI Dietary Study
participants had developed diabetes mellitus being treated by insulin or medications. There was
a 4% reduced risk (not statistically significant)
of developing diabetes in the
dietary change group
E+P hormone therapy should not low-fat
compared to participants in the
be used to prevent disease in
usual diet comparison group.
healthy, postmenopausal women. The low-fat dietary change
group was asked to reduce their
fat intake to 20% of energy and
to
increase
their
vegetable
and fruit intake to five
to increases in a variety of cancers, including lung
or more and grains to six or more daily servings.
cancer. After stopping the intervention, mortality
Participants who reported a significantly
from all causes was somewhat higher in women
greater reduction in fat intake after the first year
who had taken active E+P pills compared with
had a greater reduction in risk of diabetes. Howthe placebo.
Based on these findings, the overall summary ever, this reduced risk was not statistically significant after accounting for weight loss. Participants
of risk and benefits was unchanged, showing that
in the dietary change group lost nearly five
the health risks exceeded the health benefits from
pounds after the first year and maintained a lower
the beginning of the study through the end of
this three year follow-up. This follow-up confirms weight than the comparison group throughout
the study. Thus modest weight loss, rather than
the study’s main conclusion that E+P hormone
the proportion of fat, carbohydrate, and
therapy should not be used to prevent disease
protein in the diet, may be what reduced
in healthy, postmenopausal women. The most
the risk of developing diabetes. Modest
important message to women who have stopped
weight loss is typical when following
this hormone therapy is to continue seeing their
a low-fat dietary pattern that is rich in
physicians for rigorous prevention and screenvegetables, fruits, and grains.
ing activities for all important preventable health
After an average of 7 years of followconditions.
up, participants in the low-fat dietary
A low-fat
change intervention group maintained a
n Low-Fat Dietary Pattern and Risk
eating style
significantly lower fat intake (and minor
of Treated Diabetes Mellitus in
weight loss) than did participants in the
Postmenopausal Women
is an option
usual diet comparison group. This sup(Archives of Internal Medicine, July 2008)
for postports a low-fat dietary eating style that
Type 2 diabetes continues to rise in the United
has lots of vegetables, fruits, and grains,
menopausal
States. In women, this form of diabetes rises after
as
an
option
for
postmenopausal
women
menopause, increasing the risk of heart disease
women
who are concerned about developing
and reducing well-being. Fortunately, there
diabetes.
concerned
are lifestyle changes that can reduce the risk of
developing diabetes. Research from the Diabetes
about
Prevention Study in the United States (funded by

3

diabetes.

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PREVENTING

FA L L S

Preventing Falls in the Home

4

WHI08-09.indd 4

id you know that falls and fall-related injuries are more common than strokes and can
have consequences that are just as serious?
More than 30% of seniors fall each year, with the
chance of falls increasing drastically with age and
illness. Of those who fall, 20-30% suffer moderate to serious injuries, leading to problems with
daily activities like dressing, bathing, and walking around. The consequences of a fall become
more serious as we age — a broken bone can
disrupt your lifestyle, and possibly lead to disabilities that make you dependent on a caregiver
or lead to nursing home placement.

There are several common health problems and
hazards in the home that increase the risk for
falling, including:
• problems walking or moving around
• taking 4 or more medications
• foot problems
• unsafe footwear
• a drop in blood pressure when
standing up, causing dizziness
• vision problems
• tripping hazards in the
home

FA L L P R E V E N T I O N G U I D E
Follow these steps to help prevent falls in your home:
Take Care of Yourself
n Have your hearing and vision checked on
a regular basis.
n Get regular medical checkups. Review
your medications with your doctor, to
ensure you are taking the appropriate
levels and types.
n Take medication as directed and do not
skip medications. Failure to properly take
medication is a major cause of falls and
fall-related injuries.
n Talk with your health care provider about
recommending an exercise plan to help
you maintain or improve balance, gait,
and muscle tone.
n Get plenty of rest, water, and proper
nutrition.
n Be aware of how you feel. If you do not
feel well, be sure to walk slowly and
deliberately, or ask someone to help you.
n Use a cane or walker if one has been
prescribed.

Remove Hazards
n Remove throw rugs that slide or fasten
them to the floor with carpet tape. If you are
buying a rug for the bathroom and kitchen,
make sure it has a non-skid backing.
n Keep cords and clutter from pathways.
n Arrange furniture to make sure you have a
clear pathway between rooms. Make sure
you have 38-42 inches of clearance in your
walking path.
n Remove low coffee tables, magazine racks,
footstools, floor plants, and anything that
is easy to trip over from your walkways.
n Clean up spills right away.
n Use sturdy stepstools with handrails. If you
use a ladder, make sure it’s secure.
n Make sure that your sidewalks and walkways are level. If they are not, ask for help
in having them repaired.

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WHI08-09.indd 5

Even if you are not seriously hurt, be sure to mention the
fall to your personal physician, since falling can be a sign
of illness or problems with medications.

n Do not place items on or at the top of
stairs, where you can trip over them.
n Add a contrasting color strip to the first
and last steps of a stairway to show where
the level changes.
n Place phones in several rooms in case you
need to call for emergency help.

FA L L S

Protect Yourself and Your House
n Wear safe footwear – shoes or slippers with
non-skid soles.
n Hold on to steady furniture if you are
unsteady on your feet.
n Be especially careful in the fall “trouble
spots” – the bathroom and kitchen. Install
grab bars near sinks, toilets, and showers.
n Use a shower chair or transfer bench when
getting in and out of the bathtub.
n Keep your home well lit, and turn on the
lights when walking through dark rooms
or hallways.
n Use nightlights in bathrooms, bedrooms,
and hallways.
n Keep a flashlight handy at all times in case
of power failure.
n Store lightweight or rarely-used objects on
the top shelves of cabinets.
n If you must climb to reach something, use
a sturdy step ladder with hand railings.
n Install handrails on both sides of stairways.

If you ever should fall, call 9-1-1, and if
any type of cover is in reach, try to keep
yourself warm with a blanket or rug.

PREVENTING

The good news is that by increasing your awareness and making modifications to your home,
most falls are preventable. The box below highlights some of the things you can do
to make yourself and your home
safer. Studies have shown that by
taking as many of these
steps as possible, you
can decrease your
likelihood of falling. This is a case
where prevention
may truly be the
best medicine!

5

Outside Your Home
n Make sure outside doors, patios, porches,
steps and walkways are well lit.
n Keep outside steps and walkways clear
of obstacles and in good condition (for
example, have cracks repaired).
n Make sure there are handrails on both
sides of exterior steps, and be sure to use
them.
n Be extra careful walking outside when the
sidewalks are wet, icy, or snowy.

10/26/08 4:47:04 PM

THE WOMEN OF WHI

The Women of WHI

6

n the 1990s, over 160,000 women
chose to join the largest study on
women’s health ever done, and they have
been making history ever since! The
160,000 women who joined the original
WHI, and the 120,000 who continued in
the WHI Extension Study, are a remarkable group of women. They are nurses,
doctors, teachers, homemakers, nuns,
scientists, volunteers, caregivers, mothers,
grandmothers, aunts, sisters – in short,
they form a tapestry representing women
across the US. Each and every participant
has her own story to share – a small number of which we’ve featured in previous
issues of WHI Matters, and in the quilt
stories on the WHI participant website
(www.whi.org). While it is not possible
to cover the story of every participant, we
will continue to share as many

The women of WHI
form a tapestry
representing women
across the U.S.
as we can. Here are just a few of the many
interesting and accomplished women of
WHI.

WHI08-09.indd 6

Inspiring Women for Over 60 Years
Eula Raye Cook
started exercising
at the age of 12,
which was very
unusual in the small
town in the Blue
Ridge Mountains
of North Carolina
where she was
raised. She didn’t
have any particular
inspiration – she
just thought it
seemed like a good
idea at the time –
but she did try to
inspire her friends
to become active
with her. At the
“I’d like to inspire
age of 74, Eula still
exercises regularly
women in WHI
and can touch her
to take charge
toes with ease, which
of their health
she attributes to the
by eating right,
benefits she’s gained
from exercising her
keeping active in
whole life. She still
the right way, and
enjoys playing golf,
getting plenty
bowling, and dancing,
of sleep.”
and is active in the
Blue Ridge Senior
– Eula Raye Cook
Games. In September
2008 she participated
in Doubles Bowling, the fun walk, and the 5-K
Race-Walk, where she won the bronze medal!
As Eula explains, “I raised 5 children and
worked full time, and still found time to do
my exercises each day. Because of this I have
benefited greatly with almost perfect health
throughout my life. I’d like to inspire women
in WHI to take charge of their health by eating
right, keeping active in the right way, and getting
plenty of sleep.” Eula has been an inspiration to
girls since the age of 12, and it clearly continues
through today!

10/26/08 4:47:05 PM

WHI Bags Continue to
Travel the World

Letters
We’d love to hear feedback on the newsletter.
We regret that we cannot answer questions about
individual medical conditions. Send a letter to:
WHI Matters
Fred Hutchinson Cancer Research Center
1100 Fairview Ave N, M3-A410
P.O. Box 19024
Seattle, WA 98109

WHI08-09.indd 7

Marti Serviente, participant at the Newark
Clinical Center, recently modeled attire from
the 1970s in a Heart Week fashion show at
her local mall. When not modeling, she does
fundraising walks
for the YMCA,
donates blood,
takes Caribbean
cruises, and enjoys
spending time with
her 5 children,
8 grandchildren,
and 9 greatgrandchildren.
Marti, whose
mantra is “how
lucky can I get?”
says she’s grateful
to be living in a
“It’s a warm fuzzy feeling to
time when WHI
think of so many women,
is available, and
so many places, participating
that she feels good
to be part of such
for the good of all.”
a large study. Like
– Marti Serviente
many participants,
she feels that her
life has been healthier because of the WHI study
results. “I’m 91 now”, says Marti, “and I still
do aerobics and have an active social life. It’s a
warm fuzzy feeling to think of so many women,
so many places, participating for the good of all.
Thanks WHI!” We say thank you, Marti, for your
contributions to WHI, and for showing us how
great 91 can be!

THE WOMEN OF WHI

Bonnie Noonan, a Madison clinical center participant, and her well-traveled WHI bag, visited
the Great Wall of China in Beijing in 2006.
While there, she climbed the great wall, visited
the Forbidden City, and saw the initial construction of the Olympic Bird’s Nest stadium. She
also noticed a flurry of cleaning, painting, and
refurbishing going on in Beijing, all in preparation for the 2008 summer games.
Bonnie, the mother of two daughters and
six step-children, was employed at the USDA
before retiring. When her children were younger,
she worked as a Licensed Practical Nurse at
the Phantom Lake YMCA camp for several
summers, which she greatly enjoyed. Her real
passion now is travel; in addition to China, she’s
visited Ireland,
Israel, Hawaii,
and Jamaica,
and taken
cruises to the
Caribbean and
Alaska. She’s in
the process of
planning the
next big trip
for her and
her WHI bag
– to the South
American
country of Peru!

91-year-old Fashion Model

7

Staff Information
WHI Matters is produced by the WHI Coordinating
Center at the Fred Hutchinson Cancer Research
Center.

Editor: Julie Hunt, Ph.D.
Design: Sunny Bay Design

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Stay in Touch
Don’t forget to call your local Clinical Center if your
address or phone number changes!
Albert Einstein College of Medicine
Bronx, New York • (718) 931-1010
Arizona Prevention Center
Phoenix, Arizona • (800) 341-7672
Tucson, Arizona • (520) 321-7440
Baylor College of Medicine
Houston, Texas • (713) 798-4033

C E N T E R   I N F O R M AT I O N

Berman Center for Clinical Research
Minneapolis, Minnesota • (612) 341-7921 or
(800) 789-8380

8

Medical College of Wisconsin
Milwaukee, Wisconsin • (414) 805-7040
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island • (401) 729-2865
Nevada Clinical Center
Reno, Nevada • (775) 784-4906
New Jersey Medical School
Newark, New Jersey • (973) 972-2944
New Brunswick, New Jersey • (732) 235-6546
Northwestern University
Chicago, Illinois • (312) 908-5790
Ohio State University
Columbus, Ohio • (614) 688-3563
Rush-Presbyterian St. Luke’s Medical Center
Chicago, Illinois • (312) 563-2209

University of California, San Diego
Chula Vista, California • (800) 514-0325
La Jolla, California • (800) 514-0325
University of Cincinnati
Cincinnati, Ohio • (513) 584-6061
or (888) 558-6062
University of Florida
Gainesville, Florida • (352) 392-1920
Jacksonville, Florida • (352) 392-1920
University of Iowa
Davenport, Iowa • (800) 344-3515
Des Moines, Iowa • (515) 241-8989
Iowa City, Iowa • (800) 814-9535
University of Miami School of Medicine
Miami, Florida • (305) 243-4800
University of North Carolina
Chapel Hill, North Carolina • (919) 966-3165
or (800) 342-0770

Brigham and Women’s Hospital
Chestnut Hill, MA • (617) 732-9860

Stanford Women’s Health Initiative
San Jose, California • (650) 725-5307

Center for Health Research
Portland, Oregon • (503) 335-2400

Stony Brook Clinical Center
Stony Brook, New York • (631) 444-9800

Charlton Memorial Hospital
Fall River, Massachusetts • (401) 729-2865

South Bay WHI Program
Torrance, California • (310) 222-2217

Detroit Clinical Center
Detroit, Michigan • (313) 966-8000

UAB Preventive Medicine
Birmingham, Alabama • (205) 934-2294

Emory University
Decatur, Georgia • (404) 370-7355

UCLA Women’s Health Initiative
Los Angeles, California • (310) 825-9502

Evanston Hospital
Evanston, Illinois • (312) 908-5790

UMASS/FALLON Clinical Site
Worcester, Massachusetts • (508) 856-5452

Fred Hutchinson Cancer Research Center
Seattle, Washington • (206) 667-6551

University at Buffalo
Buffalo, New York • (716) 829-3128

The George Washington University
Washington, DC • (202) 741-2323

University of California, Davis
Sacramento, California • (916) 734-5562

WHI of the Triad
Greensboro, North Carolina • (336) 716-2243
Winston-Salem, North Carolina •
(336) 716-2243

Kaiser Permanente – Bay Area Clinic
Oakland, California • (510) 891-3201

University of California, Irvine
Orange, California • (714) 456-8685

Women’s Health Hawaii
Honolulu, Hawaii • (808) 441-5555

University of Pittsburgh
Pittsburgh, Pennsylvania • (412) 624-3598
or (800) 552-8140
University of Wisconsin
Madison, Wisconsin • (608) 261-1867
UTHSC
San Antonio, Texas • (210) 567-1850
UT Prevention Center
Memphis, Tennessee • (901) 448-8405
WHI of the Nation’s Capital
Washington, DC • (202) 675-4770

If you have any questions about the WHI Extension Study, or if your address or phone number changes, please call your WHI
clinic at the number listed above. If you have moved to a new area, you should contact the center where you originally joined
the study. There are still WHI staff on hand at your clinical center to record address changes and answer your questions. Thank you!

Women’s Health Initiative
Clinical Coordinating Center
1100 Fairview Ave N, M3-A410
P.O. Box 19024
Seattle, WA 98109-1024
2008-09

WHI08-09.indd 8

PRSRT STD
U.S. POSTAGE

PAID

SEATTLE, WA
PERMIT NO. 1147

Change Service Requested

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