R01CA263144

Salsa - Study of Active Lifestyle Activation - Project Summary / Abstract

Children and adolescents diagnosed with cancer now have, on average, nearly 85% 5-year survival. However, premature cardiovascular (CV) disease has become the leading non-cancer cause of late mortality among childhood cancer survivors.

There is a robust body of evidence from the general population, and increasingly, among cancer survivors (even those exposed to cardiotoxic cancer therapies), that greater physical activity (PA) and improved diet quality can reduce future CV-related morbidity. However, while many general population and cancer-specific intervention studies have focused on a single lifestyle factor (e.g., PA or diet alone), given the interplay between PA and dietary factors in influencing CV health, a multi-faceted approach may result in overall better long-term CV health profiles.

Research on lifestyle interventions in cancer survivors also has been predominantly conducted in women with breast cancer, and the evidence for survivors of childhood cancer is limited.

To accomplish our aims, we will use the largest prospectively followed childhood cancer survivor cohort in the world, the Childhood Cancer Survivor Study (CCSS; N>24,000), to recruit adult-aged participants at increased risk of early CV disease (N=403) for a remotely conducted 12-month randomized controlled trial testing a multi-faceted approach at improving PA and diet quality.

Specifically, the study will use a sequential multiple assignment randomized trial (SMART) design, where participants with low PA or poor diet will first be randomized between intervention and control conditions. Intervention participants will be further randomized to receive either clinician-led telehealth sessions focused on risk factor self-management, or weekly mobile health (mHealth) supported individualized PA and dietary goal-setting with social media peer support.

The adaptive SMART design will allow further tailoring of the intervention experience based on initial response, which may increase overall intervention efficacy. Participants not initially responsive to their assigned intervention will be further randomized to receive an alternate intervention.

The study will use consumer-grade mHealth applications that track PA and diet, thereby increasing future dissemination capacity. The study's primary analyses will determine the overall intervention efficacy and whether specific intervention strategies and sequence of strategies are associated with optimal outcomes.

Secondary analyses will examine potential predictors, mediators, and moderating factors associated with PA and dietary changes over time, as well as changes in participants' cardiometabolic profiles.

In summary, lifestyle change represents one of the few available strategies to mitigate CV risk in childhood cancer survivors. Significant barriers (e.g., time, training, resources) limit the ability of healthcare systems to facilitate such change. To fill this void, remote-based, personalized, and easily disseminated multi-faceted mHealth-supported interventions may play a transformative role.

Fred Hutchinson Cancer Center

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. 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 THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

Seattle, Washington 981094433 United States

Single Zip Code

Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors (R01 Clinical Trial Optional) (RFA-CA-20-027)

Amendment Since initial award the total obligations have increased 409% from $735,984 to $3,744,546.