Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Participants are exposed to the "Get Behind Your Health!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.

Participants are exposed to a Healthy Eating "Peaches!"- media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.

"Get Behind your health"

Participants are exposed to a "Healthy Eating!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.

Peaches

Electra Paskett

The purpose of this project is to implement and evaluate an intervention to increase and sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based participatory research (CBPR) in combination with two CRC interventions that have been developed and piloted with community partners to improve CRC screening

PRIMARY OBJECTIVES:

I. Utilize CBPR methods to develop specific county-level media campaigns and a clinic-based chart reminder for 12 Ohio Appalachia counties focused on CRC screening or an attention control message.

II. Implement and test, using a group-randomized design, a staggered county-wide intervention program that consists of county-specific media campaigns, clinic-specific chart reminder systems, and a combination of both strategies in 6 randomly selected intervention counties vs. an attention control condition in 6 randomly selected control counties.

III. Utilize process and outcome evaluation strategies to assess the efficacy of each strategy.

IV. Utilize the results to plan the dissemination of the intervention into 36 Appalachian counties in 6 additional states of the Appalachia Community Cancer Network (ACCN) in a subsequent study.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Participants are exposed to the "Get Behind Your Health!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.

Arm II: Participants are exposed to a media campaign, patient education material in clinics, and a combination related to healthy eating, "PEACHES" (Promoting Education in Appalachia on Cancer and Healthy Eating Styles). Participants also undergo telephone interviews during years 2-4.

CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

Community-Based Participatory Research(CBPR)Strategies in Increasing Colorectal Cancer(CRC)Screening in Participants in Ohio Appalachia

The primary research question is whether the intervention will affect the rate of CRC screening-within-guidelines among age-eligible residents in the participating counties. The primary outcome is CRC screening-within-guidelines status defined as having any one of the following: 1) FOBT in the past year; 2) flexible sigmoidoscopy in the past 5 years; 3) FOBT annually + flexible sigmoidoscopy in the past 5 years; 4) double-contrast barium enema in the past 5 years; or 5) colonoscopy in the past 10 years.

Though randomization of 12 counties to each condition from within strata reduces the likelihood that there will be any imbalance in important prognostic factors between the two conditions, confounding remains a possibility in any single realization of an experiment. Left alone, such imbalance could confound the true relationship between condition and the outcomes. To avoid this problem, we will examine prognostic factors measured at baseline for evidence of any imbalance; if it is present, we will perform secondary analyses in which we repeat the primary analysis adding the potential confounders as additional covariates, attending carefully to issues of measurement error which can create problems for such adjustments. Regression adjustment cannot completely correct for confounding, but to the extent that the confounders are well measured and properly modeled, the adjusted analysis will reduce the confounding.

Other secondary analyses will explore the assumption of homogeneity of the intervention effect across subgroups of participants. Though power will be limited for interactions, we will add subgroup main effects and interactions in order to explore possible effect modification. The primary subgroup variables will be gender and age group (age 55-64 vs. age 65+).

National Institute on Minority Health and Health Disparities (NIMHD)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

The educational intervention is that parents and providers receive materials about HPV by mail including HPV/ cervical cancer videos and brochures, fact sheets, HPV/cervical cancer resource lists. Clinics receive posters, brochures, tabletop/reminder cards, resource lists, newsletters, and "invitation to be vaccinated" letters for parents.

The educational intervention is that parents and providers receive materials about Flu by mail including Flu brochures, fact sheets, Flu resource lists. Clinics receive posters and brochures.

Receive HPV vaccination educational materials

educational intervention

Receive influenza vaccination educational materials

This clinical trial studies an educational intervention for parents and providers in increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia. Educational interventions may be effective in increasing the number of participants whose daughters receive HPV vaccination.

PRIMARY OBJECTIVES:

I. Implement a multi-level HPV vaccine educational intervention directed at 3 levels within participating 12 Ohio Appalachia counties that includes information about cervical cancer, cervical cancer screening, HPV, the HPV vaccine, communication skills training to improve parent-health care provider conversations about the HPV vaccine, and organizational level components.

II. Evaluate the effectiveness of the multi-level HPV vaccine educational intervention in a group randomized controlled trial in 12 Ohio Appalachia counties.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Parents and health care providers receive educational materials about HPV vaccination by mail or in-person review with project staff including a culturally tailored HPV and cervical cancer educational video and brochures, a question and answer (Q \& A) fact sheet, and a HPV and cervical cancer resource list. Clinics receive waiting and exam room posters and brochures, tabletop cards, reminder cards to mail to participants, an information resource list, newsletter, vaccine tracking system, and "invitation to be vaccinated" letter to mail to parents.

Arm II: Parents and health care providers receive educational materials about influenza vaccination by mail or in-person review with project staff.

After completion of study, participants are followed up at 3 and 6 months.

The Parents in Appalachia Receive Education Needed for Teen Project

The Ohio State University Center for Population Health and Health Disparities Community Awareness, Resources and Education (CARE II): Project 4 The PARENT (Parents in Appalachia Receive Education Needed for Teens) Project

A logistic random effects model will be used. A t-test of the coefficient for intervention status will be used to determine if there is a difference in the expected proportion of vaccinated patients across treatment arms.

Separate logistic random effects models will be fit for each vaccination and t-tests of the fixed intervention effect will be used to compare treatment arms.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia	NCT01904656	Colon Cancer Rectal Cancer	"Get Behind you... Peaches	51 Years - 75 Years	Ohio State University Comprehensive Cancer Center
The Parents in Appalachia Receive Education Needed for Teen Project	NCT01901770	Healthy Human Papilloma...	educational int... educational int...	18 Years -	Ohio State University Comprehensive Cancer Center

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