R01CA241143

Sphere (Survivorship Plan Health Record) Implementation Trial - Project Summary/Abstract

The Institute of Medicine recommends that each cancer patient receive a survivorship care plan that summarizes information important to the individual's long-term care, including the following: (1) cancer type and treatments, (2) their potential consequences, (3) recommendations regarding preventive practices, and (4) specific information about recommended follow-up.

Despite their clinical importance, gaps in CRC surveillance care and preventive care exist among CRC survivors. Unmet symptom needs are also prevalent and undertreated. We propose to evaluate the capacity of an interactive survivorship care plan (SCP) delivered through an internet-based personal health record (PHR) to meet the needs of CRC survivors.

PHRs combine health information and medical data with knowledge management and software tools to potentially enable patients to become active participants in their own care. A SCP delivered via an appropriately designed PHR may promote increased concordance with CRC surveillance and preventive care guidelines through the exchange of health information between CRC survivors and healthcare providers. A survivorship care plan-personal health record (SCP-PHR) may also improve care for symptoms through the combination of longitudinal PHR-based symptom measurement and tailored self-management tools.

To understand the effectiveness of the SCP-PHR, we will conduct a randomized clinical effectiveness trial at the patient level. We will assess the impact of the SCP-PHR across a variety of measures and outcomes, including CRC surveillance, preventive care receipt, patient symptoms, and patient-centered quality.

To simultaneously understand the effectiveness and implementation of the SCP-PHR, we will conduct a hybrid Type I effectiveness-implementation trial consisting of the following components: (A) a randomized clinical effectiveness trial at the patient level, and (B) a mixed methods implementation study. The mixed methods portion of the study will consist of a quantitative evaluation of patient attitudes toward technology associated with the frequency and patterns of SCP-PHR use, as well as a qualitative process evaluation using semi-structured interviews to assess facilitators and barriers to implementation of the SCP-PHR among key stakeholders: patients, healthcare providers, and organizational leaders.

This study design will enable us to meet the simultaneous needs of understanding the effectiveness and the healthcare context of SCP implementation.

Trustees Of Indiana University

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.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

Indianapolis, Indiana 462025112 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 380% from $649,730 to $3,117,615.