Pilot Studies 2005-2006
Pilot Studies 2004-2005
Exercise Training & Fatigue in Women with Breast Cancer
Principal Investigator: Dr. Sadeeka Al-Majid
Co-investigator: Peter Pidcoe
A growing body of research with persons having cancer-related fatigue indicates that engaging in regular endurance exercise can attenuate self-reported fatigue. There is some evidence suggesting that regular endurance exercise increases functional capacity, improves the distance walked, enhances quality of life (QOL) in persons with cancer and reduces depression. Very little, however, is known regarding the biological mechanisms through which endurance exercise may reduce cancer-related fatigue and produce such beneficial effects. Based on the existing literature, it is not clear if endurance exercise attenuates cancer-related fatigue by changing biological variables at the muscle level, such as muscle endurance or strength. In addition, research on the relationship between the biological and the behavioral outcomes of exercise in this patient population is scarce. Thus, this pilot study is designed to examine the influence of structured endurance exercise training on fatigue-related biological and behavioral outcomes among women undergoing adjuvant chemotherapy and/or radiation for stage II breast cancer. Interactions among biological and behavioral responses will be investigated with the intent to improve biobehavioral outcomes associated with the critical health experience of cancer-related fatigue. The specific aims of this pilot study are to (1) investigate the influence of a structured endurance exercise program on a number of fatigue-related biological and behavioral factors, including muscle strength, muscle endurance, VO2 max and cardiopulmonary fitness, distance walked, self-reported fatigue, depression, and quality of life in women with breast cancer; and (2) pilot test the components of the research design to evaluate the exercise protocol, recruitment and retention of participants including minorities, and the feasibility of implementing the exercise protocol.
Analytic Extension of Cranial Stimulation for Chemo Symptoms in Breast Cancer
Principal Investigator: Dr. Debra E. Lyon
This pilot study extends the specific aims of the previously funded R21 award through the use of Bio-Rad technology, which allows for multiple, simultaneous cytokine measures. In the R21, the cytokine analysis was limited by the blood required to do a single ELISA (approx 3 ccs) and the high cost of the individual cytokine assays. Using the Bio-Rad multiplex system, we will be able to assess the relationships among multiple cytokines, which will assist in the selection of cytokines as outcome measures for the forthcoming R01 grant application (June, 2006).
Due to the inconclusive results of previous studies and the heightened interest in better understanding and identifying the biological markers associated with fatigue and depressive symptoms, the specific aims of this study are to extend the R21 grant by
- further describing the occurrence and severity of fatigue and depressive symptoms in women prior to their first chemotherapy treatment, and
- exploring the relationship between each symptom (fatigue and depressive symptoms) and theoretically related proinflammatory and angiogenic cytokines as well as cytokine profiles using recent innovations in measurement systems.
Serum for this study will be accessed from the samples previously obtained and cryopreserved for the larger study, 7 R21 CA106149-02, Cranial Stimulation for Chemo Symptoms in Breast Cancer (Lyon, Debra E., PI). We will use the sera collected prior to the first chemotherapy because of the potential confounding effects of chemotherapy on cytokine expression.
Biopsychosocial Health in Female Cancer Survivors
Principal Investigator: Dr. Gayle M. Roux
Research on cancer survivors suggests that either as result of having cancer or the treatment (chemotherapy or radiation), there is a higher rate of depression, decreased quality of life (QOL), weight gain and non-cancer co-morbid conditions such as heart disease and diabetes continue or worsen (Dow, 2003; Dow, Ferrell, Haberman, & Eaton, 1999; Dow et al., 1996; Ferrell & Dow, 1997; Ganz, 2001; Polinsky, 1994; Roux, Bush, & Dingley, 2001). A gap in knowledge exists on comprehensive health needs and the best timing of in terventions tailored to survivorship issues in the first year post-treatment to address these issues. Epidemiologic studies have shown that increased physical activity is associated with decreased risk for recurrent breast cancer and the incidence of colon cancers, decreased weight gain and depression, and enhanced QOL. However, the scientific evidence on the amount, type, and intensity of physical activity to recommend immediately after cancer treatment is unknown. Nor is it established at what point the client has returned to a level of function and immune status post-treatment at which they can tolerate and are physically and mentally ready to initiate an increase in exercise. In order to address these gaps in knowledge, a pilot study is needed to describe the basic relationships among biopsychosocial components of health status in this population. Thus, this cross-sectional pilot study will examine numerous health status variables among women during the first year post-treatment for stage I, II, and III abdominal and breast solid tumor cancers. This study will provide preliminary evidence for the next step in the program of research, i.e., to address the timing, amount, type and intensity of physical activity indicated in this population. Ultimately, this knowledge will lead to empirically based directions for future interventions aimed at improving health outcomes for women surviving cancer.
The specific aims for this pilot study are congruent with the goals of the Center for Biobehavioral Clinical Research (CBCR) to examine the integration of biological and behavioral variables in the context of cancer survivorship. The specific aims of this pilot study are to:
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Describe women in terms of their health status (including immune status, symptomatology, and anthropometric variables), as well as psychosocial indicators of health status (depression, inner strength, quality of life, psychological well-being, and confidence in self-management) during the first year post treatment for stage I, II, or III solid tumor cancers.
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Describe women regarding their survivorship experiences in relation to resource needs, greatest challenges, previous history of exercise, and their perceived readiness and the best timing to initiate an exercise program after treatment.
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Evaluate participant recruitment strategies (especially for minorities and women with various cancers) and the feasibility of obtaining measures 0-12 months following cancer treatment.
This cross-sectional study will examine these variables in 40 women aged 21 and older with stage I, II, or III solid tumor cancers including abdominal (colorectal), genitourinary (renal, uterine, ovarian, cervical), and breast cancer. Participants will have finished any chemotherapy and radiation regime.
Lifestyle and Cardiovascular Risk Factors in Liver Transplant Recipients
Principal Investigator: Dr. Jeanne Salyer
Liver transplantation, an accepted treatment for some individuals with end stage liver disease, has long-term survival rates at 1, 3, and 5 years reported as 85.7, 77.6, and 72.1%, respectively (retrieved January 20, 2005 at www.optn.org/latestData/rptStrat.asp ). Ten year survival rates of 60% have also been documented in some studies of long-term survivors (Gonwa, 2001; Kizilisik et al., 2003; Planas et al., 2004). Liver transplant recipients share the same cardiovascular risk factors as the general population (Fernandez-Miranda et al., 2002; Johnston et al., 2002; Reuben, 2001), as well as other risk factors for atherosclerotic cardiovascular disease associated with immunosuppressant therapy (Neal et al., 2001; Rabkin et al., 2002; Varo et al., 2002). As a result of the additive nature of these risk factors, the incidence of cardiovascular disease is much higher in transplant recipients than in the general population. For example, the annual cardiovascular mortality rate is increased from 0.28% in the general population to 0.54% in renal transplant recipients where it accounts for 55% of the overall mortality. Up to 10% of the late mortality in liver transplant recipients has been attributed to cardiovascular disease (Rabkin et al., 2001); thus, it is one of the most frequent non-immune causes of death in this population (Asfar et al., 1996). Some cardiovascular risk factors, such as obesity, hypertension, dyslipidemia, and diabetes mellitus, occur frequently after liver transplantation (Munoz, 1995; Varo et al., 2002). In addition to risks conferred as a result of family history or other non-modifiable factors, the risk of acquiring atherosclerotic cardiovascular disease is increased (Reuben, 2001). Dietary changes, weight reduction, and exercise are mainstays of risk reduction therapy (Reuben, 2001); however, few studies have been conducted of lifestyle characteristics and their relationship to cardiovascular risk factors in liver transplant recipients. Thus, the primary aims of this pilot study are to:
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Describe lifestyle characteristics (physical activity, dietary habits, smoking) and cardiovascular risk factors (dyslipidemia, hypertension, overweight/obesity, body fat distribution, metabolic syndrome, impaired glucose tolerance, plasma homocysteine concentrations, C-reactive protein) in long-term ( > 3 years post-transplant) liver transplant recipients.
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Determine whether or not relationships exist between lifestyle characteristics and cardiovascular risk factors and delineate differences based on individual characteristics such as gender, race, education, type of transplant, immunosuppressive therapy regimen, physical activity level, smoking, and presence of metabolic syndrome.
The secondary aim is to:
- Evaluate instruments and measures selected to evaluate lifestyle characteristics and cardiovascular risk factors from a biobehavioral perspective in this patient population.
Measures of Oral and Pulmonary Health in COPD Patients
Principal Investigator: Anne Boyle
Chronic obstructive pulmonary disease (COPD) is a critical health experience of increasing
significance. Preliminary evidence suggests an association between COPD and oral health status,
which means that improving oral health might be a simple and cost-effective way to impact this
group of patients. Although epidemiologic reports have reported this connection, the relationship
between oral and sputum inflammatory markers has not been investigated, and no intervention
studies to improve oral health have been reported. This proposal represents an initial step
toward a planned intervention study of oral health in persons with COPD. The specific aims of
this study are to (1) determine the feasibility of collecting and measuring the proposed
indicators of oral and respiratory inflammation in COPD patients, and (2) investigate the
relationship between inflammatory markers and other measures of oral health and pulmonary
status in COPD patients. A sample of 45 patients will be drawn from all patients over
the age of 18, who attend the asthma/ COPD clinic at the Veterans Administration Medical
Center (VAMC) in Richmond, Virginia. All data collection will be obtained during one clinic
visit. Sputum samples will be assessed for amount, color, viscosity, MPO, cytokines, LTB4,
neutrophil count, Gram stain and culture. Measures of oral health will include DMF, plaque
score, neutrophil count, oral cavity culture, and pocket measurement, as well as salivary
volume, IgA, lactoferrin, and salivary inflammatory markers. Spearman's correlations will
be generated to assess the relationship between the oral variables and the pulmonary
function/sputum variables. Because the oral flora variable is categorical an analysis
of variance model will also be used to look for differences in the pulmonary
function/sputum means across these levels. This pilot study will provide preliminary data
for an eventual intervention study that addresses the role of improvement of oral health
in COPD.
Measuring the Oral Health of Nursing Home Elders
Principal Investigator: Rita Jablonski
Nursing home acquired pneumonia (NHAP) is a critical health experience that accounts for
considerable morbidity, mortality, and costs to nursing homes (NHs) and the health care system.
While studies have demonstrated a link between oral helth and NHAP, comprehensive assessment of
oral health status in NH residents has not been done, little is known about oral care provided
by formal caregivers, and evidence based protocols for oral care to reduce NHAP have not been
developed. The purpose of this study is to test procedures surrounding the collection of oral
health indices in a NH population, as pilot dat for developing and testing an intervention
aimed at reducing NHAP. Specific aims of this pilot study are to: 1) test the feasibility of
obtaining data measuring the oral health of NH residents, including plaque measurements on
dentures and dental surfaces, presence of respiratory pathogens in the oral cavity, state
of natural teeth, saliva flow, and the presence of salivary IgA levels; 2) describe the types
and frequency of oral care provided by nursing assistants to cognitively-impaired NH residents
through the use of surveys; and 3) determine the relationship between oral health indices and
dentate status. The specific aims will be accomplished using a prospective, descriptive
design. NH residents (n=39) and certified nursing assistants (n=50) from 2 NHs will
participate. Efforts will be made to recruit NH subjects to reflect the three types of
dentitions (dentate, mixed dentition, and dentures only). Data to be collected from NH
residents include indices of oral helath (including those listed in specific aim 1),
functional status, cognitive status, reported oral health regimens, and NHAP incidence.
CNAs wil participate through completing a survey regarding practices of oral care
provision to NH residents. Descriptive data will be examined, and correlational and
multiple regression analysis will be used to understand the relationships among variables. |
