SBIR-STTR Award

Recruiting Underserved Populations Into Clinical Trials with Customizable Media
Award last edited on: 9/13/2017

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$963,691
Award Phase
2
Solicitation Topic Code
393
Principal Investigator
Charlene Anne Caburnay

Company Information

Health Communication Impact LLC (AKA: Health Communication Research Laboratory)

5899 Nina Place
Saint Louis, MO 63112
   (314) 550-2849
   ccaburnay@hcimpact.com
   N/A
Location: Single
Congr. District: 01
County: St. Louis city

Phase I

Contract Number: 1R44CA192442-01
Start Date: 9/1/2015    Completed: 7/31/2017
Phase I year
2015
Phase I Amount
$542,908
Racial and ethnic minorities, older adults and those from rural communities continue to be underrepresented in cancer and other clinical trials research, despite annual spending on patient recruitment in excess of $1 billion. While many individual studies have demonstrated that targeted outreach and education to underrepresented patients and engagement of front line providers in community hospitals can help boost participation in clinical trials, few of these strategies have evolved into scalable systems that cn support recruitment efforts across many organizations simultaneously with demonstrated efficacy. MIYO (Make It Your Own) is an online tool that addresses this challenge. MIYO helps healthcare organizations develop and use professional quality recruitment materials to increase research participation among underrepresented groups. In minutes, organizations can create their own versions of audience- tested small media for the specific patients they serve by choosing from a menu of approaches recommended by the Guide to Community Preventive Services, then customizing them by choosing from a library of images, messages and graphic designs. Creations can be printed, e- mailed, texted, used online or distributed in other ways to target audiences. In a wide range of Phase I equivalent studies, MIYO has been used to promote HPV vaccination, use of tobacco quit lines, colorectal cancer screening, and use of clinical trials recruitment materials. Findings from this research shows that MIYO is well liked and easy to use; helpful in designing outreach and education products that are targeted for vulnerable population sub-groups, and effective in increasing audience responses like a calling 1-800-4-CANCER. The proposed Direct to Phase II study will expand the Clinical Trials Participation module in MIYO and evaluate its effectiveness in getting patients to enter Pioneers, a research recruitment registry. In partnership with the Midwest Cancer Alliance, we will randomize its 22 community hospital and health center members to either an active MIYO condition or delayed use control, and compare rates of enrollment overall and in priority sub-groups 12 months pre- and post-implementation of MIYO. Increased and more diverse participation in clinical trials will improve the lives of cancer patients and their families, and elp eliminate cancer health disparities in the U.S. population.

Public Health Relevance Statement:


Public Health Relevance:
The burden of cancer on U.S. adults is tremendous and disproportionate among certain population sub-groups. Clinical trials are one of the main pathways to reducing that burden, but participation rates are low, especially among those most affected by cancer. Our study will examine the uptake and effects of an online tool to help healthcare organizations develop and use evidence-based, professional quality recruitment materials to increase research participation in underrepresented groups.

NIH Spending Category:
Aging; Cancer; Clinical Research; Clinical Trials and Supportive Activities; Lung; Lung Cancer; Prevention; Rural Health

Project Terms:
Address; Adult; Affect; anticancer research; Cancer Burden; cancer health disparity; Cancer Patient; Characteristics; Clinical; Clinical Research; Clinical Trials; Code; colorectal cancer screening; Communication; Communities; Community Health Centers; Community Hospitals; Controlled Study; Databases; design; Education and Outreach; Effectiveness; Elderly; Electronics; Enrollment; evidence base; Family; Goals; Healthcare; Human Papilloma Virus Vaccination; Image; improved; Individual; Internet; Investments; Judgment; Libraries; Literature; malignant breast neoplasm; Malignant neoplasm of cervix uteri; Malignant Neoplasms; member; Minority; Minority Groups; older patient; Outcome; Outcome Study; Pathway interactions; Patient Recruitments; Patients; Phase; phase 2 study; Physicians; Population; Preventive; Printing; Provider; public health relevance; quitline; Randomized; Recruitment Activity; Registries; Reporting; Research; Research Infrastructure; Research Personnel; response; Rural; Rural Community; Services; Site; System; Target Populations; Testing; Tobacco; Tobacco use; tool; treatment site; Underrepresented Minority; Underserved Population; uptake; Vulnerable Populations; Work

Phase II

Contract Number: 5R44CA192442-02
Start Date: 9/1/2015    Completed: 7/31/2017
Phase II year
2016
Phase II Amount
$420,783
Racial and ethnic minorities, older adults and those from rural communities continue to be underrepresented in cancer and other clinical trials research, despite annual spending on patient recruitment in excess of $1 billion. While many individual studies have demonstrated that targeted outreach and education to underrepresented patients and engagement of front line providers in community hospitals can help boost participation in clinical trials, few of these strategies have evolved into scalable systems that cn support recruitment efforts across many organizations simultaneously with demonstrated efficacy. MIYO (Make It Your Own) is an online tool that addresses this challenge. MIYO helps healthcare organizations develop and use professional quality recruitment materials to increase research participation among underrepresented groups. In minutes, organizations can create their own versions of audience- tested small media for the specific patients they serve by choosing from a menu of approaches recommended by the Guide to Community Preventive Services, then customizing them by choosing from a library of images, messages and graphic designs. Creations can be printed, e- mailed, texted, used online or distributed in other ways to target audiences. In a wide range of Phase I equivalent studies, MIYO has been used to promote HPV vaccination, use of tobacco quit lines, colorectal cancer screening, and use of clinical trials recruitment materials. Findings from this research shows that MIYO is well liked and easy to use; helpful in designing outreach and education products that are targeted for vulnerable population sub-groups, and effective in increasing audience responses like a calling 1-800-4-CANCER. The proposed Direct to Phase II study will expand the Clinical Trials Participation module in MIYO and evaluate its effectiveness in getting patients to enter Pioneers, a research recruitment registry. In partnership with the Midwest Cancer Alliance, we will randomize its 22 community hospital and health center members to either an active MIYO condition or delayed use control, and compare rates of enrollment overall and in priority sub-groups 12 months pre- and post-implementation of MIYO. Increased and more diverse participation in clinical trials will improve the lives of cancer patients and their families, and elp eliminate cancer health disparities in the U.S. population.

Public Health Relevance Statement:


Public Health Relevance:
The burden of cancer on U.S. adults is tremendous and disproportionate among certain population sub-groups. Clinical trials are one of the main pathways to reducing that burden, but participation rates are low, especially among those most affected by cancer. Our study will examine the uptake and effects of an online tool to help healthcare organizations develop and use evidence-based, professional quality recruitment materials to increase research participation in underrepresented groups.

NIH Spending Category:
Aging; Cancer; Clinical Research; Clinical Trials and Supportive Activities; Lung; Lung Cancer; Minority Health; Prevention; Rural Health

Project Terms:
Address; Adult; Affect; anticancer research; Cancer Burden; cancer clinical trial; cancer health disparity; Cancer Patient; Characteristics; Clinical; Clinical Research; Clinical Trials; Code; colorectal cancer screening; Communication; Communities; Community Health Centers; Community Hospitals; Controlled Study; Databases; design; Education and Outreach; Effectiveness; Elderly; Electronics; Enrollment; ethnic minority population; evidence base; Family; Goals; Health; Healthcare; Human Papilloma Virus Vaccination; Image; improved; Individual; Internet; Investments; Judgment; Libraries; Literature; malignant breast neoplasm; Malignant neoplasm of cervix uteri; Malignant Neoplasms; member; Midwestern United States; Minority; older patient; Outcome; Outcome Study; Pathway interactions; Patient Recruitments; Patients; Phase; phase 2 study; Physicians; Population; Preventive service; Printing; Provider; quitline; racial and ethnic; racial minority; Randomized; Recruitment Activity; Registries; Reporting; Research; Research Infrastructure; Research Personnel; response; Rural; Rural Community; Site; System; Target Populations; Testing; Tobacco; Tobacco use; tool; treatment site; Underrepresented Groups; Underserved Population; uptake; Vulnerable Populations; Work