Research Projects: Cancer Prevention and Control Program
Rural Cancer
Survivors/Health Disparities
Prevalence and Health Status of Cancer Survivors in the Rural US (R03CA156641; PI: Weaver,
Co-Is: Case)
is a study that used data from the National Health Interview Survey to
generate the first population-based estimate of the number of US
cancer survivors who reside in rural areas and to describe their
socio-demographic and cancer characteristics, health behaviors,
health care utilization, and health status (self-reported health,
psychological distress, non-cancer comorbidities, and unemployment
due to health).
Cancer-related Follow-up Care Experiences of Rural Cancer Survivors (R03CA157211;
PI: Weaver; Co-Is: Avis, Tooze). This study surveyed breast,
prostate, and colorectal cancer survivors (n=174) who were two to
five years post-diagnosis and resided in rural areas. Key topics of
interest included characteristics of post-treatment follow-up care
received, barriers to follow-up care, health-related information
needs, and adherence to screening and surveillance guidelines.
End of Treatment Transition to Follow-Up Care among Early Stage
Lung Cancer Survivors (R03CA179019;PI: Weaver, PhD,
Co-Is: Tooze, Petty, Ruiz) This mixed-methods study focuses on an understudied, but growing
population, early stage lung cancer survivors, and gathered novel
data on their follow-up care transition experiences and needs. This
study recruited patients diagnosed with localized lung cancer
who completed primary treatment within the past 3-24 months to
explore lung cancer survivors' experiences in the two years after
initial treatment, focusing on their health needs, communication
with treatment team, and psychosocial concerns using both
semi-structured interview and survey research strategies.
A Primary
Care Multilevel mHealth Colorectal Cancer Screening (mCRC) (R01CA178941; PI: D. Miller,
Co-I: Weaver) This
project is evaluating the efficacy of an innovative multilevel
mHealth colorectal cancer (CRC) screening intervention (mCRC)
designed for primary care practices that incorporates a tablet
computer CRC screening decision aid and text messaging support.
This randomized clinical trial will evaluate: 1) the ability of the
mCRC system to increase receipt of CRC screening within 24 weeks of
enrollment, 2) potential mechanisms of change by which the mCRC
system facilitates screening, and 3) the additional cost of the
mCRC system per patient screened.
Tobacco Control
Smokeless Tobacco Use in College
Students (R01CA141643; Co-PIs: Wolfson and Spangler; Co-Is: Reboussin, Sutfin). The goal of this study is to better
understand trajectories and correlates of smokeless tobacco (SLT) use among college
students. The study team measured trajectories of SLT use among
undergraduate college students over the course of their college
careers and are analyzing data collected to identify environmental and individual-level correlates of
trajectories of SLT use. The research team is also examining patterns of use of different
SLT products, including chewing tobacco, dry and moist snuff
(including snus and other flavored products), and alternative
products (including lozenges, strips, orbs, and sticks).
Dissolvable Tobacco Perceptions and Use among Young Adults in
Test Markets (R01CA141643-04S2, Co-PIs: Wolfson and Spangler, Co-Is: Reboussin, Sutfin, Wagoner) A new generation of
dissolvable tobacco products has been introduced into test markets
in the U.S. This study assesses perceptions and use of these
products in three test markets where they are currently available
(Denver, CO, Charlotte, NC and various cities in Kansas).
This information will better enable the Food and Drug
Administration to fulfill its responsibilities regarding regulation
of these products under the Family Smoking Prevention and Tobacco
Control Act of 2009.
Tobacco Use Trajectories and Surgical Outcomes in Newly
Diagnosed Head and Neck Cancer Patients in North and South
Carolina (Joint Pilot Grant between Wake Forest Baptist Comprehensive Cancer Center and Hollins Cancer Center, Medical University of South
Carolina; Co-PIs: Weaver and Sterba; Co-Is: Janet Tooze) The goal of this
observational pilot study was to understand the influence of
smoking status on surgical outcomes in head and neck cancer
patients (n=109) and to gather preliminary data that can be used to
translate study findings into future clinic-based interventions for
head and neck cancer patients.
Effective Communication on Tobacco Product Risk and FDA
Authority (P50CA180907, PI: Ribisl, PD: Sutfin, Co-Is: Reboussin, Wolfson,
Wagoner). The Center for Regulatory Research on Tobacco Communication is a partnership with UNC Lineberger Comprehensive Cancer Center and one of 14 NIH/FDA-funded Tobacco Regulatory Research Centers. The goal of this center grant is to
advance regulatory science by using communication science to
improve messages about cigarette smoke constituents, emerging
tobacco products, and the FDA's regulatory authority over tobacco. The Center aims to conduct three integrated research projects
among vulnerable populations and across the lifespan to inform
regulatory science.
Large Epidemiologic Studies/Resources Covering Multiple
Content Areas
Wake Forest NCI Community Oncology Research Program (NCORP) Research Base (UG1CA189824; PI: Lesser; Co-Is: Weaver, Danhauer, Rapp, Vitolins). NCORP research bases serve as a conduit for
community-based research through its 837 practices.The WF NCORP Research Base is the only NCI-designated Comprehensive Cancer Center Research Base. The Wake Forest NCORP
supports research on neurocognitive deficits, cardiotoxicity, symptom
management, and cancer care delivery research, with an emphasis on survivorship
care. The Wake Forest NCORP represents a key
inter-programmatic collaboration between the Cancer Prevention and Control Program and the Clinical Research Program.
Women's Health Initiative and WHIMS (N01WH44221; PI: Shumaker).The
Women's Health Initiative (WHI) was initiated in the early 1990s,
and was comprised of an observational cohort study of approximately
93,000 healthy women ages 50-79 at study entry. There were
also three clinical trials in WHI: 1) low fat dietary
modification (intervention vs. placebo group) of approximately
46,000 women; 2) post-menopausal hormone therapy study
(n=26,000 women) comparing estrogen only (CEE) vs. placebo for
those women with a uterus, or estrogen plus progesterone (CEE/MPA)
vs. estrogen for those women who had not had a hysterectomy, and
3) a study of Calcium and vitamin D supplements vs. placebo,
which was open to women in either the dietary modification and/or
the hormone trials. In all, approximately 162,000 women were
enrolled in either the observational or clinical trial components
of WHI. Women were recruited into WHI from 1993 - 1999.
The study was extended from 2005-2010, and then received a second
extension from 2010-2015, enrolling approximately 93,000 of the
original WHI participants. During the second extension,
regional coordinating centers for WHI were created. Wake
Forest University houses the center for the Southeastern Region of
the United States, overseeing medical outcomes data collection and
the production of papers and ancillary study proposals from WHI
data. Dr. Shumaker is the PI of our Southeastern Region
Coordinating Center.
Symptom Management and Quality of Life
Acupuncture for the Treatment of Hot Flashes (R01AT005854; PI:Avis). A recently completed trial, "Acupuncture Treatment for
Menopausal Hot Flashes" (R21CA104427; PI: Avis) randomized women
to one of three groups: true acupuncture, sham acupuncture, or
usual care. The research team found a significant decrease in mean frequency
of hot flashes, but no difference between the two acupuncture
groups, but both showing a significantly greater decrease in hot
flashes compared to the usual care group (Avis et al. Menopause,
2008). These results suggest either a strong placebo effect
or that both traditional and sham acupuncture significantly reduce
hot flash frequency. A subsequent study is currently underway
to provide greater insight into the effectiveness of acupuncture
for hot flashes (R01AT005854, "Acupuncture for Hot Flashes" PI:
Avis). This study is randomizing 200 women to examine real world
effectiveness of acupuncture for hot flashes among cancer survivors
and menopausal women.
Reducing Lung Cancer Survivor Anxiety (RELAX) with Brief
Device-Guided Breathing (R21CA182111; PI: Danhauer). Lung cancer is the second-most
common cancer diagnosed in the US, yet little "survivorship"
research has focused on this population. As the number of early
stage lung cancer (ESLC) survivors increases because of uptake in
low dose computerized tomography lung cancer screening, it will be
increasingly important to develop interventions to improve their
well-being. The goal of study is to determine feasibility of a
device-guided breathing intervention versus a music control group
and to obtain preliminary data on effects on anxiety, dyspnea,
pulmonary function, and functional fitness in ESLC survivors. This
study will enroll 60 post-treatment ESLC survivors with clinically
meaningful anxiety symptoms through two sites of the Wake Forest
NCI Community Oncology Research Program Research Base (WF NCORP RB).
Participants will be randomly assigned to one of three groups:
low-dose (15 minutes, once per day) RESPeRATE device-guided
breathing (n=20), high-dose (15 minutes, twice per day) RESPeRATE
(n=20), and music control (15 minutes, once per day) (n=20). The
results of this study will provide outstanding preliminary data for a planned R01 application for a larger randomized controlled
trial that will be run through the WF NCORP RB that can better
elucidate the impact of the proposed simple intervention for
anxious, post-treatment ESLC survivors, that can be easily
disseminated.
Investigating Mechanisms to Explain Age Associated Differences
in Quality of Life among Breast Cancer Patients (PI:Avis, Co-I: Naughton). The purpose of this study is to better
understand why younger women have greater psychological morbidity
following a breast cancer diagnosis than older women and to examine
age-related differences in treatment. This prospective
observational cohort study has enrolled over 650 women and followed
them for 2 years post diagnosis and provides a rich resource for
manuscripts related to cancer survivorship.
Lifestyle Interventions
Prosocial Behavior and Volunteerism to Promote Physical Activity
in Older Adults (R01HL109429; PI: Foy, Co-Is: Vitolins, Tooze) is a 5-year randomized controlled trial that
compares the effect of a "healthy aging" control intervention
(n=150) vs. that of a physical activity intervention (N=150) which
embeds prosocial behavior and volunteerism upon physical activity
at 12 months. Three hundred men and women aged 55 to 80 years are
being randomized into the two interventions. This study involves
administration of questionnaires, direct measures of blood
pressure, body weight and size, and direct measures of physical
performance. In addition, survivors of cancer are eligible for this
study, which may provide opportunities for qualitative interviews
and assessments which address cancer survivorship.
Taking Health Realization into Valued Eating and Exercise
(THRIVE): A Feasibility Study of an Intervention to
Prevent Weight Gain for Breast Cancer Survivors during
Chemotherapy. (PI:Mihalko,
Danhauer). The goal of the THRIVE pilot
study is to demonstrate the feasibility of conducting a randomized
clinical trial to test the effectiveness of an intervention to
prevent weight gain for breast cancer survivors during
chemotherapy. This study tests the efficacy of the intervention as
a springboard to a short-term healthy lifestyle program.
A Feasibility Study of a Physical Activity Intervention in Older
Adult Inpatients with Acute Leukemia
(Intramural grant; PI: Mihalko;
Co-Is: Danhauer, Klepin). Acute myelogenous leukemia
(AML) is a disease of older adults characterized by
disproportionately worse survival associated with increasing age.
Adults undergoing intensive treatment for AML frequently experience
substantial physical deconditioning, treatment-related symptoms and
emotional distress. Development of evidence based treatment
guidelines for older adults will depend upon targeted interventions
designed to minimize the impact of therapy in this population on
physical function and quality of life. The goal of this pilot
study is to demonstrate the feasibility of conducting a randomized
clinical trial to test the effectiveness of a physical activity
intervention for older adult patients with acute leukemia who are
undergoing induction or reinduction chemotherapy on physical and
psychological health.
Omega-3 PUFA-Gene Interaction
in Prostate Cancer (R01CA163273; PI:
Chen). The goal of this research is to study the
interaction between dietary PUFA and their metabolic enzymes in
prostate cancer. This research team has previously shown that I3 PUFA
reduced prostate cancer (PCa) growth, slowed histopathological
progression and increased survival, whereas I6 PUFA had the
opposite effects. They hypothesize that I3 PUFA is primarily
metabolized by Cox1 in vivo and that the anti-proliferative effect
of I3 PUFA is, in part, mediated by Cox1 metabolite(s).
Furthermore, I6 PUFA is metabolized by Cox1, Cox2 and Lox5, and the
corresponding metabolites play important roles in stimulating PCa
growth. To test this hypothesis, three specific aims are proposed:
(1) Study the cellular mechanism(s) of PUFA-gene interaction on PCa
growth, (2) Identify metabolite(s) of I3 and I6 PUFA important in
PCa and (3) Examine metabolite signaling in PCa cell proliferation
and apoptosis.
Late Effects of Cancer Treatment
Resonance Imaging Trial for Heart bioMarkers (RITHM) in AYA
Cancer Survivors (R21CA159557; PI:
Castellino; Co-I: Hundley). Treatment of childhood cancer has been one of the
resounding successes of medicine in the last half of the 20th
century, as 1 in 640 young adults in the US is a survivor of
childhood cancer. With increased person-years of life impacted,
cardiovascular (CV) disease is now the leading cause of non-cancer
death in childhood cancer survivors. Anthracycline chemotherapy is
a major risk for this CV morbidity and mortality. A lack of
functional markers of CV risk has limited cardioprotection and
secondary prevention strategies. Cardiac magnetic resonance imaging
(CMR) provides precise measures of aortic and cardiac function,
making it ideal for establishing surrogate markers of subclinical
disease in smaller populations. This project is an observational
clinical trial with a cross-sectional and longitudinal design to
evaluate the application of CMR in detecting subclinical markers of
cardiac injury after anthracycline therapy. The research team is using CMR to
measure aortic stiffness and myocardial wall strain in
adolescent/young adult survivors of childhood cancer off therapy in
comparison to a control group without cancer. In addition they are evaluating the ability of CMR to detect and follow changes in aortic
function in newly diagnosed adolescent patients receiving
anthracycline chemotherapy. The trial at two childhood cancer
programs will lead to: novel CMR biomarkers of subclinical
anthracycline cardiotoxicity, an understanding of previously
unexplored concepts of aortic stiffness and myocardial strain in
the pathophysiology, and the establishment of a young anthracycline
exposed cohort who can be followed with CMR for future studies of
the technology and targeted interventions.
Early Imaging Detection of CV Injury after
Cancer (R01CA167821; PI: Hundley). In collaboration
with Siemens Medical Solutions, this project develops a new
magnetic resonance imaging (MRI) scanner for detecting early
subclinical vascular toxicity secondary to cancer chemotherapy.
This technical and methodological solution for cancer
investigations establishes an innovative methodology to detect the
risk for early cardiovascular disease, and thereby enable timely
new preclinical therapy guidelines designed to reduce potential
cardiovascular events and thus improve the overall survival of
those treated for cancer.
Cognition
Cognitive functioning is an important area of cancer survivorship
as researchers are increasingly finding cognitive deficits
following cancer treatment. More research needs to be
done on the exact nature of these deficits, identification of risk
factors for cognitive deficits, and possible interventions to
prevent or slow these deficits. Cognition is a strong area at
WFUSM in population sciences, basic sciences, and radiation
oncology and several multidisciplinary groups are already
addressing these issues.
Women's Health Initiative Memory Study (PI:
Shumaker). A
long standing ancillary study to WHI is the Women's Health Initiative
Memory (WHIMS) suite of studies. These studies were developed
by Dr. Shumaker and colleagues and the WHIMS coordinating center is
also located at WFSM. Beginning in 1996, the WHI included a
unique and detailed assessment of global cognitive functioning,
mild cognitive impairment, and dementia on a subset of
women (aged 65 and older) who were enrolled in the WHI hormone
trials (N=7,450). Follow-up of about 3,700 of these
women still continues. The Women's Health Initiative Study of
Cognitive Aging (WHISCA) and the Women's Health Initiative Magnetic
Resonance Imaging (WHIMS-MRI) study were conducted on subsets of
WHIMS participants. In addition, the Women's Health
Initiative Memory Study of Younger Women (WHIMS-Y) began in
2008.
This study is designed to assess the long-term impact
of random assignment to postmenopausal hormone therapy among women
who were 50-54 years of age at the time they were initially
enrolled into the WHI hormone trials. Hormone therapy
continues to be widely prescribed for the treatment of menopausal
symptoms. There remains a strong belief among basic and
clinical scientists that hormone therapy begun during the peri- or
immediate post-menopausal periods may bestow cognitive benefits and
that the cognitive harm associated with hormone therapy in the
post-menopausal woman occurs only when there is some pre-existing,
sub-clinical disease and/or the aging brain is more vulnerable to
the possible negative effects of hormones. This specific
issue was not addressed within the original WHIMS cohort, and
WHIMS-Y takes advantage of the rich WHI cohort by adding critical
information on the clinical treatment of peri-menopausal and early
post-menopausal women and on potential mechanisms of action for how
HT may affect cognition.
Both WHI and WHIMS provide a wealth of opportunities to study
factors related to cancer prevention and control, as well as
survivorship, due to rich data on dietary habits, exercise, social
support, comorbidities, quality of life and health
disparities.
Gene-Hormone Interaction and Risk of Breast
Cancer (R01CA149135; Co-PIs: Sun, Vitolins). The overall hypothesis of this study is
that common genetic variants can be used to classify women into low
or neutral risk groups for developing breast cancer due to HT use
(gene-hormone interaction). The research team specially hypothesize that 1) a
subset of genetic variants account for individual differences in
risk of developing breast cancer upon HT use (E+P or E only) on
breast cancer risk, 2) those SNPs may or may not alter the risk of
developing CVD upon HT use. We will identify the genetic variants
using data and samples from the Hormone Therapy Trial (HT) of the
Women's Health Initiative (WHI) study, a large randomized,
double-blind, placebo-controlled clinical trial, and perform a
replication study in the WHI Observational Study (OS). To test
these hypotheses, we have four specific aims. Aim 1 is to identify
SNPs that account for individual differences in risk of developing
breast cancer upon HT use (SNP-HT interactions). Aim 2 is to
confirm the top significant SNPs identified in Aim 1 among women in
the OS arm. Aim 3 is to evaluate the SNP-HT interaction with other
phenotypes (primarily CVD) among women in the OS arm. Aim 4 is to
estimate the individual absolute risk of developing breast cancer
upon HT use among women in the OS arm. The identified genetic
variants will be used to create a risk-benefit profile for HT
treatment and may potentially improve clinical decision making for
HT use.
The Study of Women's Health
Across the Nation (SWAN) (U01AG12546; Wake Forest PI:
Avis) is a large multi-site,
multi-ethnic 15-year study of mid-aged women as they transition
through menopause. The dataset includes psychosocial factors,
health risks and health behaviors, physiological measures, and
disease outcomes. The data provide the opportunity to
prospectively examine cancer survivorship among those women who
develop cancer over the course of the study and to compare health
status to healthy controls. An ancillary study focused on cancer
survivors is planned for the Fall.