Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

After completing eligibility and baseline surveys, Lay health workers delivered an educational intervention for breast and cervical cancer screening. This educational session was delivered in participants' home and lasted between 1-2 hours. Follow-up data was collected 4-6 months post educational session.

No intervention was delivered. At baseline, participants completed eligibility and baseline surveys. Follow-up data was collected 4-6 months post-baseline survey.

A lay health worker delivered educational intervention for breast and cervical cancer screening.

In total, the Intervention Group subject participation will take approx. up to four hours (1 hour for interview, 1 hour for the second interview, and 1-2 hours for the CLS intervention) and Control Group up to four hours (One hour for interview, one hour for the second interview, up to two hours for educational intervention after the second interview).

Follow-up data was collected 4-6 months post education session (intervention group) or post-baseline survey (control group).

Cultivando La Salud

Vivian Colón-López, PhD

The overall goal of this education program is to increase breast and cervical cancer screening in low-income women in Puerto Rico through implementation of an evidence-based educational program that addresses both health professionals (promotoras or community health workers) and public audiences of low-income women living in Canóvanas, Puerto Rico who have either never been screened for breast and/or cervical cancer, or are under-screened according recommended guidelines. To evaluate promotoras' delivery of the CLS screening education program we used a randomized pre-post comparison group study design that will provide data to determine the effectiveness of the CLS intervention program compared with usual practice (no intervention).

The proposed promotora and community based breast and cervical screening education program includes the following specific aims:

Aim 1. To train community health workers (promotoras) from Taller Salud to implement the CLS breast and cervical cancer screening program. Taller Salud staff train and build capacity of promotoras to implement the CLS community-based education and navigation program.

Aim 2. To deliver the CLS intervention program to at least 600 women in Canóvanas municipality, Puerto Rico.

Aim 3. To evaluate the impact of the program on increasing mammography and cervical cancer screening among participating women in Canóvanas, Puerto Rico.

Aim 4. To adapt and update intervention materials

A randomized controlled trial using a pre-post comparison group design. Eligibility criteria included ages 21 and older for the Pap cohort and 40 and older for the mammography cohort, non-adherence to recommended Pap test screening and/or mammography screening guidelines according to the American Cancer Society, no hysterectomy, no diagnosis of cancer, and not currently pregnant. Trained data collectors administered a baseline survey to eligible women and randomly assigned them to the intervention or to a comparison condition. Lay Health Workers delivered the intervention in women's homes, and administered the follow-up survey by phone 4 to 6 months following baseline.

Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women

Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last Pap test.

Screening behavior status at baseline and follow-up were assessed by asking women the month and year of their last mammogram.

The University of Texas Health Science Center, Houston

University of Puerto Rico

Professor

Kirsten Y Eom, PhD

Jacqueline Dolata

This study offers Hispanic women who are eligible for cervical cancer screening residing in the Cleveland metropolitan area one of two possible community outreach-based cervical cancer screening modalities, self-collection home HPV test or clinic-based pap test, which is the current standard of care, to assess if these strategies improve cervical cancer screening rates in this population group.

This study is an observational community outreach-based feasibility study. The study intervention that is being evaluated includes two different strategies of cervical cancer screening: 1) a self-collection home HPV test and 2) an in-office pap test. Study subjects who choose the self-collection home HPV test will be provided with the following materials: 1) research information sheet that explains the study objective, the expected timeline of the results, 2) a letter recommending a routine pap test regardless of whether they chose to complete the self-sampling HPV test, 3) educational materials on how to self-collect and return a sample, and 4) a FDA-approved self-sampling kit. Self-collected samples will be tested by the FDA-approved procedure. Study subjects will be asked to choose the screening method of their preference: a self-collection HPV testing kit at home and return the kit within 1 month to the study team or a pap test at a local clinic, which is scheduled within a month. The at-home test only includes vaginal swab and not collection from the cervix. The study team will be notified of the results of HPV test or of pap test and inform the study subjects. If the study subject reports the study team of the loss of her home HPV test kit, it will be recorded as a study outcome of "loss of home HPV test kit". Study subjects who do not return their HPV test kit within 4 weeks will receive 3 reminder calls within a week.

Study subjects who choose an in-office pap test will be scheduled for an annual gynecological exam that includes a pap test at a local clinic that the participant prefers by the study team. The standard-of-care in gynecology at the local clinic involves annual gynecological exam. Study subjects who choose an in-office pap test will receive two appointment reminder calls by the study team a week and three days prior to the scheduled appointment, respectively. No returning of the self-sampling home HPV kit and no show to the scheduled appointment for pap test will be recorded as study outcomes, and these study subjects will be considered enrolled in the study.

Community Outreach-based Study to Increase Cervical Cancer Screening Among Hispanic Women in Cleveland

Using a Community-based Participatory Approach to Reduce Disparities in Cervical Cancer Prevention, Screening, and Diagnosis Among Hispanic Women in Cleveland

Either return of a mailed home HPV test kit or receipt of in-office Pap test

MetroHealth Medical Center

Breast Diseases

Skin Diseases

Motivational Interviewing (MI) Intervention includes in -person home visit that elicits behavior change by helping participants explore and resolve ambivalence. A telephone follow-up call also uses MI technique.

An individual-level intervention that implements a motivational interviewing intervention led by a promotora

Motivational Interviewing Intervention

Shirley AA Beresford, PhD

Gloria D Coronado, PhD

¡Fortaleza Latina! is a multi-level randomized trial to increase participation in mammography screening among Latinas who seek care at a community health center in Western Washington.

In partnership with the partnering community health center, we have obtained lists of women patients aged 42 to 74 years old who had not had a mammogram in the last two years and resided within defined radii of the four clinics. Baseline and one year follow-up surveys will be obtained by in person home interview. Participants are randomized within clinic to intervention or comparison group. The intervention consist of two motivational interviewing sessions, one in person in the home, and one telephone follow-up. The study hypothesis is that a higher proportion of participants in the motivational interviewing arm will obtain a screening mammogram within the study period than those in the comparison arm.

Breast cancer is the most common cancer among Hispanic women in the United States (US) and five-year survival from breast cancer is lower in Hispanic than in non-Hispanic White women. This reduced survival has a number of potential causes, but differential screening rates may be a partial explanation, since Hispanic women have lower breast cancer screening rates than non-Hispanic White women. The overall purpose of the study is to develop and evaluate a culturally-appropriate intervention aimed at increasing screening mammography rates in a clinic-based sample of predominantly Mexican American women in Western Washington.

The recruitment goal of the Fortaleza Latina study is approximately 500 Latina women aged 40-74 who have had a clinic visit within the past 5 years, but no recent mammogram, from the four selected Community Health Center clinics. After providing informed consent and completing a baseline assessment, eligible women are randomly assigned to intervention or comparison group, within clinic. The individual-level intervention implements motivational interviewing (MI) in two participant encounters. MI is a direct counseling style, led by a promotora (lay health advisor), that elicits behavior change by helping participants explore and resolve ambivalence.

Of the 2194 women contacted by field interviewers, a total of 710 surveys have been completed; of these, 542 were eligible and have been randomized and enrolled into the Fortaleza Latina study (279 intervention, 263 usual care).

Screening Mammography and Latinas: A Multilevel Intervention

Understanding and Preventing Breast Cancer Disparities in Latinas: Screening Mammography and Latinas: A Multilevel Intervention

Cost of intervention is set against potential savings in treatment costs associated with late diagnosis

Through medical record review at one year follow up, women will be classified as receiving or not receiving mammography screening since baseline assessment

At the one year follow-up women are asked have they ever had a mammogram, and then when was the most recent mammogram. responses are used in conjunction with date of baseline survey.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women	NCT04617236	Breast Cancer Cervical Cancer	Cultivando La S...	21 Years -	University of Puerto Rico
Community Outreach-based Study to Increase Cervical Cancer Screening Among Hispanic Women in Cleveland	NCT05470309	Cervical Cancer		30 Years - 65 Years	MetroHealth Medical Center
Cultivando la Salud: A Breast and Cervical Cancer Screening Promotion Program for Low-Income Puerto Rican Women	NCT04617236	Breast Cancer Cervical Cancer	Cultivando La S...	21 Years -	University of Puerto Rico
Screening Mammography and Latinas: A Multilevel Intervention	NCT02010008	Breast Cancer	Motivational In...	40 Years - 74 Years	Fred Hutchinson Cancer Center

Spots Global Cancer Trial Database for hispanic women