Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Obesity

Colorectal Neoplasms

Inflammation

Colonic Neoplasms

Adenoma

Recurrence

Insulin Resistance

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

We are evaluating the effects of a legume enriched, low glycemic index, high fermentable fiber diet, on CRP, and C-peptide participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps. In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets. 65 male participants were recruited and randomized into four groups. A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas. In addition, potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation, including mRNA from exfoliated fecal colonocytes. To our knowledge this is the first controlled feeding study: 1. to examine the effects of legumes or a low GI diet on markers of inflammation

LIFE

Matthew R Young, Ph.D.

This study, sponsored by the National Cancer Institute and Penn State University, will examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and polyps. Many scientists believe that colon and rectal cancers develop from polyps (tumors of the lining of the large bowel). This study will test whether a high-legume diet can reduce levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as C-reactive protein) that at elevated levels are known to increase the risk of colorectal polyps and colon cancer.

Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn State University in University Park, Pennsylvania. Candidates are screened with blood tests and measurements of height, weight, and blood pressure. All candidates must have had a colonoscopy within 2 years of entering the study. They may or may not have had adenomas and may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney disease, diabetes, or other serious medical condition, and they must have no history of colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel disease. Participants undergo the following tests and procedures:

* Caloric requirement testing: The subject's resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet. A special clear plastic hood is placed over the subject's head while his breathing is measured. He can communicate with the technician at all times during the 30-minute test.
* Study diet: Subjects follow two required 4-week diets with a 3-week break in between, followed by an optional third 4-week diet. Subjects eat a healthy American diet for both of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto, baked, and navy beans are added to one of the two required diets. For the third (optional) diet period, subjects are given the same 1-1/2 cups of legumes, but are allowed to lose weight. Participants are given packages with all of the food they are to consume during the three diet periods. They may add up to five caffeine-containing beverages per day and up to two alcoholic drinks per week. They must eat all of the food they are given and only the food they are given. Subjects are expected to maintain a constant body weight during the two 4-week required diets, and their caloric intake may be increased or decreased as needed to maintain their screening weight.
* Weight measurements: Subjects are weighed regularly at the clinic.
* Blood samples: Subjects have blood samples drawn at the mid-point of each of the two required 4-week diets and at the beginning and end of each of the three 4-week diets.
* Urine and stool samples: Urine and stool samples are collected at the beginning and end of the two required 4-week diets.

Clinical, epidemiological, and molecular studies provide compelling evidence that most colorectal cancers arise from adenomas. The epidemiology of adenomas closely resembles that of colorectal cancer itself, and prevention of adenomas will most likely prevent colorectal cancer. Insulin resistance and type 2 diabetes are emerging as significant risk factors for colorectal (CRC) cancer and adenomas. Insulin resistance is defined as impaired biological response to the action of insulin. It is characterized by compensatory hyperinsulinemia and is associated with increased risk for Type 2 diabetes. C-peptide, a marker of insulin production, is elevated in IR and is also a risk factor for CRC. Both insulin resistance and colorectal cancer are increasingly recognized as chronic, low-level, inflammatory states. C-reactive protein (CRP), an acute phase protein and a sensitive marker of sub-clinical inflammation, is a risk factor for both IR and CRC.

Analysis from the Polyp Prevention Trial (PPT), a multi-center, randomized trial of 1905 participants who had a colorectal adenoma, showed that legume consumption was significantly associated with reduction of both adenoma recurrence and advanced adenoma recurrence. Legumes are a rich source of dietary fibers and anti-inflammatory, anti-cancer phytochemicals.

We are evaluating the effects of a legume enriched, low glycemic index, high fermentable fiber diet, on CRP, (a measure of inflammation) and C-peptide (a measure of insulin resistance) in participants with four possible combinations of the risk factors insulin resistance and history of adenomatous polyps. In a randomized crossover design controlled feeding study each participant consumed the above experimental diet and a control diet for four weeks with a two week washout period between diets. 65 male participants were recruited and randomized into four groups. A secondary objective is to assess whether these endpoints change by IR status or a history of adenomas. In addition, potential fecal markers of CRC risk are being measured to assess changes in gastrointestinal inflammation, including mRNA from exfoliated fecal colonocytes. To our knowledge this is the first controlled feeding study: 1. to examine the effects of legumes or a low GI diet on markers of inflammation; 2. to compare the effects of a dietary intervention on patients with a history of colon adenomas with or without IR; and 3. to measure the effects of dietary changes in human intestinal gene expression profiles using exfoliated colonocytes.

Effect of High-Legume Diet on Colorectal Cancer Risk

The Effects of a High Legume Low Glycemic Index Diet on Insulin Resistance and Inflammation in Patients at High Risk for Colorectal Adenoma Recurrence

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Breast Neoplasms

Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

2D Mammogram

Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.

Tomosynthesis

Aalo Bistritz, MD

Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.

We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped \< 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

Tomosynthesis in Screening Mammography

A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography

Hologic, Inc.

AHS Cancer Control Alberta

Rectal Diseases

The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.

New colorectal cancer screening patient education document

The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.

Traditional colorectal cancer screening education document

Tonantzin Rodriguez, MPH

The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.

Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation

Effects of Comprehensibility of Colorectal Cancer Screening Educational Materials on Patient Knowledge and Motivation: A Randomized Controlled Trial

California Academy of Family Physicians

University of California, Davis

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.

Participants will be randomized to receive information on child sun protection that is publicly available.

FLARE Intervention

Yelena Wu, PhD

The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.

Enrollment

After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session.

Intervention Sessions

Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email.

Study Assessments

Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.

Family Lifestyles, Actions, and Risk Education Intervention: Version 2

The FLARE Skin Cancer Prevention Intervention for Children of Melanoma Survivors

We will examine whether sunburn occurrence decreased over time from pre- to post-intervention (Baseline through Post-Assessment 2), specifically whether the odds of sunburn occurrence are lower for FLARE compared to standard education. Additional analyses will compare sunburn occurrence between groups immediately post-intervention at Post-Assessment 1, and over the course of one year post-baseline. In all analyses, we will control for differences in sun exposure over time.

"In the past (time period), how many times did you have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.

Mean/Standard deviation of the difference in skin tone between timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.

Mean/standard deviation of the difference in sunscreen application occurrence between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you use a screen with an SPF of 30+?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in sunscreen re-application occurrence between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in long sleeved shirt occurrence between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in long pants/skirt occurrence between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in shade occurrence between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in avoidance of peak hours between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

Mean/standard deviation of the difference in time spent in the sun to get tan between timepoints.

"These next questions ask about what you have done in the past (time frame) if you were outdoors in the sun for 15 minutes or more. How often did you spend time in the sun in order to get a tan?" Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

American Cancer Society, Inc.

University of Utah

Assistant Professor, Investigator

Breast Diseases

Participate in one year of high volume (300 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment.

Participate in one year of moderate volume (150 minutes per week) aerobic exercise with free provision of a personal trainer, membership to an exercise facility, body composition assessment.

Moderate volume (150 minutes per week) aerobic exercise

Moderate Volume

Participate in one-year high volume (300 minutes per week)aerobic exercise.

High Volume

Christine Friedenreich, PhD

The Breast Cancer and Exercise Trial (BETA Trial) is a randomized controlled trial aimed at understanding what dose (or volume) of exercise will best reduce the risk for breast cancer, particularly among women who are between the ages of 50-74. The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women

Overview The proposed project is an evolution from a previous randomized controlled intervention trial conducted by the applicants known as the Alberta Physical Activity and Breast Cancer Prevention (ALPHA) Trial that examined how a one-year aerobic exercise intervention, as compared to a usual sedentary lifestyle, influenced specific hypothesized biologic mechanisms in the association between physical activity and breast cancer risk. In the proposed project, we plan to extend this research to examine how a one-year high versus moderate volume aerobic exercise intervention influences established and novel biologic mechanisms thought to influence breast cancer risk. We are specifically interested in studying what dose of exercise is required to influence the biologic mechanisms involved in breast cancer etiology.

Rationale and Significance Inadequate physical activity, high total caloric intake, and obesity, central adiposity and weight gain throughout lifetime are all clearly associated with increased postmenopausal breast cancer risk and are some of the few risk factors amenable to intervention. Over one third of breast cancer can be attributed to these three risk factors. The exact dose and type of physical activity required for breast cancer risk reduction, however, are unknown. No trials have been conducted that have systematically examined how different volumes of activity influence mechanisms in breast cancer etiology.

Study Aims The primary aim is to compare the effects of a high versus moderate volume exercise intervention on specific hormonal and biological intermediate endpoints for breast cancer in a group of previously sedentary postmenopausal women. The primary objectives will examine the effects of the interventions on measures of adiposity, insulin resistance, sex hormone levels, markers of obesity and inflammation and serum vitamin D. The secondary aim is to evaluate the impact of the high versus moderate exercise interventions among postmenopausal, sedentary women on psychosocial factors. The secondary objectives will compare the effects of the exercise interventions on quality of life and perceived stress among the participants. Adherence to the exercise intervention at 12 and maintenance of exercise at 24 months will also be assessed.

Research Plan A two-centered, two-armed randomized controlled trial is proposed. In total, 330 postmenopausal, sedentary women aged 50-74 years will be recruited from the screening programs and through media campaigns. Strict eligibility criteria will be applied to ensure that women enrolled in the study can be expected to have a change in breast cancer risk over the one-year long intervention. Randomization will be stratified on centre (Calgary or Edmonton) and on body mass index (\< or ≥27.5). The intervention arm will undertake aerobic exercise sessions of 300 mins/week for 12 months. The control arm will be asked to undertake 150 mins/week for 12 months. Baseline and 12-month measurements of adiposity (done by computerized tomography and dual energy X-ray absorbitometry scans), fitness, diet, physical activity, quality of life and stress, determinants of exercise adherence and medical, health and demographic characteristics will be made. Bloods, drawn at baseline, six and 12 months, will be assayed to measure estrone, estradiol, testosterone, androstenedione, insulin, glucose, adiponectin, leptin, interleukin-6, tumour necrosing factor-alpha, C-reactive protein and serum hydroxyvitamin D. One year after completion of the study, maintenance of physical and dietary habits will be measured. Intent-to-treat analysis will be used with a Laird-Ware mixed effects model to compare the changes from the baseline to 12-month follow-up. These data will be of direct relevance for effectiveness trials of exercise and diet for breast cancer prevention and for refinement of physical activity guidelines.

Phase 3 - To compare the effects of a high versus moderate volume exercise intervention on specific biological intermediate endpoints for breast cancer in a group of previously inactive postmenopausal women.

Breast Cancer and Exercise Trial in Alberta

Breast Cancer and Exercise Trial in Alberta: The BETA Trial

Body composition (including weight, hip circumference, waist circumference, waist-hip ratio, total body fat, subcutaneous fat, intra-abdominal fat, lean body mass, body mass index)

Measurements taken of Insulin Levels, Glucose Levels, Insulin Resistance (HOMA Score)

Measure levels of Estrone, Estradiol, Androstenedione and Testosterone

Measure levels of C-Reactive protein, Interleukin-6 and Tumour necrosis factor.

Dr. Christine Friedenreich - Study Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Webinar, Promotion, Tool Access, academic detailing + Audit and Feedback

Webinar, Promotion, and Tool Access, academic detailing + Audit and Feedback + LEAP

All sites will receive a professionally developed, 15-minute webinar that describes the tool's development (e.g., how the algorithm was designed) and a tutorial on how to use the web-site. The investigators will promote the webinar and using the tool through key local leaders. A web-link to use the tool will be placed within the lung cancer screening clinical reminder.

Webinar, Promotion, and Tool Access

Sites randomized to intensive implementation will be offered participation in the LEAP program. LEAP (Learn. Engage. Act. Program) is a multi-week, online learning collaborative using systems redesign techniques to help sites identify and overcome barriers to implementation of shared decision making (use of the Decision Precision tool).

LEAP

Providers at all sites will have access to this system. It will provide feedback on the screening and shared decision making process (e.g., number of provider's eligible patients screened for lung cancer, use of the tool, patient knowledge and satisfaction from patient surveys).

Audit and Feedback

All sites will be offered an academic detailing approach to implementation of Lung Decision Precsion. A trained detailer will travel to all sites who agree to a visit. The detailer will meet with individual primary care providers whenever possible, and groups of providers as necessary. He will present evidence for a risk-based approach to screening and how to use the tool with patients to make tailored screening recommendations.

Academic Detailing

Tanner Caverly, MD MPH

The overall goal of this project is to test two strategies for implementing a shared decision making tool to be used by providers while talking to patients about lung cancer screening. Eight participating sites will be randomized to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will survey patients to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

The overall goal of this quality improvement project is to test two strategies for implementing shared decision making, which incorporates the Decision Precision lung cancer screening tool. The investigators will use multi-site, cluster-based randomization to compare standard implementation with intensive implementation. Additionally, the investigators will determine the factors that were most important for successful implementation of the shared decision making tool. Finally, the investigators will have a human subjects research component to evaluate the effects of Decision Precision on patient's knowledge of the risks and benefits of lung cancer screening, the quality of their decision making, and their satisfaction with care.

PrOVE QUERI Project #1

Implementing Guidelines for Shared Decision Making in Lung Cancer Screening (QUE 15-286)

Screening utilization aligning with Veterans' potential screening benefit. This will be estimated by inputting CDW data into a validated model.

Obtained from patient surveys, defined as 1) adequate knowledge about the benefits and harms, and 2) values consistent with the screening decision

Collected as para data from Decision Precision website

Qualitative analysts will conduct telephone interviews with providers at each site who identify themselves as participating in shared decision making process with patients regarding lung cancer screening.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of High-Legume Diet on Colorectal Cancer Risk	NCT00339469	Inflammation Prevention and ... Colonic Neoplas... Diet Insulin	LIFE	35 Years - 75 Years	National Institutes of Health Clinical Center (CC)
Tomosynthesis in Screening Mammography	NCT01086241	Breast Density ...	2D Mammogram Tomosynthesis	40 Years - 69 Years	AHS Cancer Control Alberta
Comprehensibility of Colorectal Cancer Screening Educational Materials: Effects on Patient Knowledge and Motivation	NCT00965965	Colorectal Neop...	New colorectal ... Traditional col...	50 Years - 75 Years	University of California, Davis
Family Lifestyles, Actions, and Risk Education Intervention: Version 2	NCT04201223	Melanoma Child	FLARE Intervent...	8 Years - 110 Years	University of Utah
Effect of High-Legume Diet on Colorectal Cancer Risk	NCT00339469	Inflammation Prevention and ... Colonic Neoplas... Diet Insulin	LIFE	35 Years - 75 Years	National Institutes of Health Clinical Center (CC)
Breast Cancer and Exercise Trial in Alberta	NCT01435005	Breast Neoplasm...	Moderate Volume High Volume	50 Years - 74 Years	AHS Cancer Control Alberta
PrOVE QUERI Project #1	NCT02765412	Prevention and ...	Webinar, Promot... LEAP Audit and Feedb... Academic Detail...	55 Years - 80 Years	VA Office of Research and Development

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