R37CA248774

Optimization of a Remote Intervention to Improve Nutrition and Physical Activity in Colorectal Cancer Survivors

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) recommends normal body mass index (BMI), regular physical activity, and a healthy diet for cancer survivors. In 2018, we estimated that 38% of deaths within 5 years of diagnosis could be prevented in stage III colon cancer if all patients followed the ACS guidelines. Yet, less than 10% of CRC patients closely follow these lifestyle guidelines. Investigators have yet to optimize a lifestyle intervention, capitalizing on effective scalable components, to improve lifestyle behaviors in CRC survivors.

Critical research gaps include: 1) whether specific intervention components (e.g., text messaging, etc.) are effective, overall or in sub-groups (men vs. women, etc.); 2) insufficient focus on improving diet; and 3) few studies with remote interventions have measured biological outcomes.

To address these gaps, we propose to use the Multiphase Optimization Strategy (MOST) framework to identify effective intervention components to increase the ACS guideline score (a standardized measure of physical activity, diet, and body size) among CRC survivors. The MOST framework is an engineering-based approach to efficiently optimize behavioral interventions while managing limited resources. Our team at the University of California, San Francisco; Dana-Farber Cancer Institute; and Northwestern University have strong expertise conducting lifestyle interventions in cancer survivors, including using MOST.

Building on this experience, we propose a 12-month randomized factorial experiment among 400 CRC survivors to determine the effect of 4 candidate intervention components [text messaging, digital health tool kit (physical activity tracker, apps), health coaching, buddy training (e.g., friend, family)] on change in the ACS guideline score from 0 to 12 months. Changes in the ACS score (our primary outcome) have high potential to impact CRC survival, and it is modifiable and measurable remotely.

Our specific aims are to:

Aim 1) Identify which of 4 candidate intervention components increase the ACS guideline score at 12 months among CRC survivors. We will determine the individual and interaction effects of each component. Secondarily, we aim to:

Aim 2) Examine mediators and moderators of the intervention components' effects on change in the ACS guideline score from 0 to 12 months. We will examine social cognitive theory constructs as primary target mediators and sociodemographic, clinical, and psychological/behavioral factors as potential moderators. This aim will help us understand how and for whom the intervention components affect lifestyle behaviors.

Aim 3) Examine the ACS guideline score in relation to levels of fasting insulin, glucose, HOMA-IR, and inflammatory markers at enrollment and 12 months. The data from all three aims of this proposal will guide our next step to conduct a definitive randomized controlled trial to evaluate the effect of the optimized intervention versus standard care on risk of CRC recurrence.

Overall, this proposal is a critical step toward developing an effective and scalable lifestyle intervention to reduce CRC mortality with the potential for high public health impact.

San Francisco Regents Of The University Of California

TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

San Francisco, California 94143 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-18-559)

Amendment Since initial award the total obligations have increased 434% from $705,777 to $3,771,145.