Lucile Adams-Campbell, Ph.D.

Professor of Oncology Associate Director, Minority Health & Health Disparities Research Georgetown Lombardi Comprehensive Cancer Center

Any inequity of treatment or services whether based on ethnicity, geography, gender, age, disability, mental health, education, and occupation; as well as, differences in health conditions attributed to environment or social issues that create inequality

1927 First funding for cancer research 1937 Congress established NCI 1971 War on Cancer declared 1973 SEER Program established 1985 Heckler Report on health disparities 1990 DHHS Healthy People 2000 report 1999, 2002 IOM Reports 2000 DHHS Healthy People 2010 report 2006 IOM Report on health disparities research

Combined data from the National Program of Cancer Registries as submitted to CDC and from the Surveillance, Epidemiology and End Results program as submitted to the National Cancer Institute in November 2010. http://www.cdc.gov/cancer/breast/statistics/race.htm

U.S. Mortality Files, National Center for Health Statistics, CDC. http://www.cdc.gov/cancer/breast/statistics/race.htm

Compared to Whites, Black women

Higher stage at diagnosis More aggressive tumors Higher incidence among younger women Less breast conserving surgery Less adjuvant therapy ??? Long-term treatment adherence More weight gain Higher obesity Poorer physical functioning More comorbid conditions

Weight reduction may improve survival outcomes

Flegal et al, JAMA, February 1, 2012Vol 307, No. 5

1995

1998

2000

2005

2008

Age-adjusted Percentage of U.S. Adults Who Were Obese or Who Had Diagnosed Diabetes
Obesity (BMI 30 kg/m2) 1994 2000 2008

No Data

<14.0%

14.0-17.9%

18.0-21.9%

22.0-25.9%

>26.0%

Diabetes 1994 2000 2008

No Data

<4.5%

4.5-5.9%

6.0-7.4%

7.5-8.9%

>9.0%

CDCs Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes/statistics

Figure 3: Trec Conceptual Model

Macro-Level Factors (Contextual)

Socio-cultural Factors

Environmental Factors

Institutional/ Policy Factors

Micro-Level Factors (Individual)

Physiological Factors*

Behavioral Factors*

Genetic Factors

Energy Balance, Obesity, Weight, Energetics

Cancer
*Physiological and Behavioral Factors contribute to the additional factors of Personality (e.g. extraversion), Psychological Factors (e.g. , stress), and Cognitive Factors (e.g. beliefs)
Macro-level factors represent variables outside the individual that serve as the context s in which obesity and energy imbalance develop. Micro-level factors represent variables within the individual that contribute to obesity, energy imbalance, and the links between energy balance and carcinogenesis. These macro- and micro-level factors are complex and interactive. Physiological and behavioral factors also form psychological (e.g., stress), personality, and cognitive factors (e.g., efficacy) that contribute to energy balance (not displayed).

Metabolic syndrome is a cluster is conditions that increases the risk of heart disease, stroke, and diabetes. This definition includes 3 or more of the following conditions: - Insulin Resistance - Central Obesity - Hypertension - Low HDL Cholesterol - High Triglycerides
Beilby, J. Definition of Metabolic Syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association Conference on Scientific Issues Related to Definition. Clin Biochem Rev. 2004 August; 25(3): 195198.

No. of Metabolic Abnormalities, % (SE)

>1

>2

>3

>4

White
AfricanAmerican MexicanAmerican

68.4(1.5)
80.0(1.0)

40.7(1.5)
51.3(1.3)

22.8(1.1)
25.7(1.3)

9.2(0.6)
10.0(0.9)

3.0(0.3)
2.3(0.5)

84.0(0.9)

57.7(1.4)

35.6(1.5)

14.7(1.3)

3.1(0.6)

Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002; 287: 356359

Rosato et al, Annals of Oncology, Volume 22 December 2011

Breast Cancer n=81 n Metabolic Syndrome High Blood Pressure Abdominal Obesity 48 49 70 % 59.2 60.5 86.4

Controls n=81 n 30 24 54 %

OR (95% CI)

37.0 2.47 (1.314.65) 29.6 3.64 (1.89-6.98) 66.7 3.18 (1.45-6.98)

0.0005 0.0000 1 0.003

Bold values represent significant differences or associations between groups Porto, LA, Lora, KJ, Soares, JC, Costa LO. Metabolic syndrome is an independent risk factor for breast Cancer Arch Gynecol Obs. January 2011

New York Times Editorial, April 24, 2010 Repairing the clinical trials system is critical not only for health care reform but for the health of millions of Americans.

Aging of the US population Contribution to population growth:

14% for Non-Hispanic Whites 45% for populations of Hispanic origin

Growth of the Black population by 10 million 45% increase in cancer incidence 99% increase in cancer incidence Smith BD et al. J Clin Onc. 2009; 27:2758-65; disparities http://www.census.gov/population/www/pop-profile/natproj.html (Accessed 11/12/10)

YES! But we need.

Molecular risk markers to accurately identify subjects and predict responsiveness of treatment Better agents to improve risk/benefit ratio Targeted agents for more personalized approach Validated biomarkers

Physician barriers: Most physicians do not offer clinical trials to patients Patient barriers: Patients are more likely to consider if recommended by their physician Our messages and education must be better tailored to both patient and physician

Co-morbidities
Renal Disease Heart Disease

Renal Disease
Hyperlipidemia Pulmonary Dis. Elicit Drugs HTN DM Heart Disease

HTN DM Hep/Liver Dis. Thyroid Dis. DVT

HIV/AIDS

ETOH Use

GI + Pancreatitis

Hep/Liver Dis.
Thyroid Dis. DVT HIV/AIDS GI + Pancreatitis Genitourinary

Genitourinary Sleep Apnea

Tobacco use

Arthritis Psychiatric Dis. Active Infections 2ndary cancers Tobacco use ETOH Use Elicit Drugs Pulmonary Dis.

Arthritis
2ndary cancers Active Infections Psychiatric Dis.

Sleep Apnea

Hyperlipidemia

Wolff, et al. ASCO-NCI Sym 2010

 Associated

with risk, recurrence and survival Alters treatment efficacy Predisposes to adverse drug reactions Decreases QOL Higher prevalence among racial and ethnic minorities and other underserved populations

Study Design

Interventions

Moderators/ Sociodemographic Factors

Awareness Barriers/ Promoters

Opportunity Barriers/ Promoters

Acceptance/ Refusal Barriers/ Promoters

Opportunity

Awareness

Acceptance/ Refusal

Measures of Success

Ford JG et al., Cancer. 2008; 112:228-42.

20 18 16 14 12 10 8 6 4 2 0
us t re

M is tr Fe ar C ul tu

Ford JG et al., Cancer. 2008; 112:228-42.

D Pr ov id er fo rt ed -r e la t is co m Fa m ily C Tr os an ts sp or ta tio n R el Ti ig m io e us Lo be w lie he fs al th lit er ac y

9 8 7 6 5 4 3 2 1 0
Protocol Adherence Patient Mistrust Patient Costs Data Collection Costs/Burden Eligibility Clinical Trials Patient (cultural competence)

Are there available trials for this patient? Is provider aware of available trials? Lack of opportunity at system level

Yes

No

No

Yes

Provider Perceptions of / Attitudes toward Clinical trials Patient mistrust of research/ medical system Data collection costs/burden

Lack of opportunity at provider level

Does provider tell patient about trials?

Adherence to study protocol No Yes Patient eligibility Method of communication / presentation

Cultural Competency Cultural Competency

Costs to patient

Opportunity Acceptance/ Refusal

Patient Awareness

Howerton et al., 2007

9 8 7 6 5 4 3 2 1 0
Eligibility Protocol Length of study/visit structure

A "collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community, has the aim of combining knowledge with action and achieving social change to improve health outcomes and

Helps overcome mistrust Improves communication strategy Mobilizes community resources Yields mutual benefits
Community gains experience with research process Data more likely to inform community action More successful recruitment strategies

Increases participation of underrepresented populations

To compare the impact of a supervised facility-based and a home-based exercise intervention on obesity, metabolic syndrome and known breast cancer biomarkers in postmenopausal AA women with metabolic syndrome who are at increased risk of breast cancer

6 months, three-arm RCT Sample size: 240 women

Supervised facility-based exercise group
1000 New Jersey Ave SE site Supervised by an exercise physiologist 3 sessions/week 150 min/week target

Home-based exercise group

Exercise amount measured in steps/day using pedometers (10,000)

Control
Instructed to maintain current habits

Inclusion criteria
African American women Between 45-65 years of age Postmenopausal WC >35 inches (88cm) 5 years individual invasive breast cancer risk >1.66% (CARE model) At least two of the following:
Fasting glucose >100 mg/dl; HDL-C <50 mg/dL; TG >150 mg/dL; BP >130/85 mmHG

Study Design

Interventions

Moderators/ Sociodemographic Factors

Awareness Barriers/ Promoters

Opportunity Barriers/ Promoters

Acceptance/ Refusal Barriers/ Promoters

Opportunity

Awareness

Acceptance/ Refusal

Measures of Success

Adapted from Ford JG et al., Cancer. 2008; 112:228-42.