Enhancing Cancer Prevention and Control Pathways-Native Health Initiative

NCT04259762 | Completed Results DMC

• 2 other identifiers: 18-264P20GM103451
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

There are continued disparities in cancer incidence, mortality, and survival between American Indians (AIs) and Whites on cancers responsive to early screening (i.e., breast, colorectal, and cervical) in the US. In New Mexico (NM), AIs compared with other racial/ethnic populations are significantly less likely to adhere to recommended screening guidelines. The purpose of this trial is to develop and pilot test multilevel/multicomponent intervention strategies to enhance screening for breast, colorectal, and cervical cancers.

Conditions

Cancer, Breast; Cancer, Colon; Cancer, Cervix

Keywords

breast neoplasm; colorectal neoplasm; cervical neoplasm; screening; behavioral interventions; American Indians

Outcome Measures

Primary Outcomes (3)

• Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers

  The focus group discussion documents the participants' knowledge about, barriers and support for, and communications about cancer and cancer prevention. Focus group methodology is primarily a qualitative research method and directly quantifying themes is not the typical approach. In this research, only qualitative data were collected with no quantification other than of the number of participants that endorsed a particular theme

  12 months

• Aim 4, Community Survey, Descriptive: Cancer Control Needs

  Age/gender specific self-reported screening behaviors for breast, colorectum, and cervical cancers

  7 months

• Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening

  Self-reported receipt of a screening exam, or scheduling an appointment for a screening exam, or self-reported attempt to make an appointment for a screening exam. Cancer-specific screening exams included FOBT/FIT/Colonoscopy for colorectal cancer for men and women 45-75 years, Pap smear for cervical cancer for women 21-75 years, or mammogram for breast cancer for women 45-75 years

  8 months

Study Arms (1)

Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening

EXPERIMENTAL

The study staff will administer to eligible participants the pre-INT and post-INT surveys. The post-INT surveys will be administered approximately 8 months after delivering the INTs. The participants will receive the INT(s) immediately after completing the pre-INT surveys.

Other: Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions

Interventions

Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions OTHER

Adult men and women will receive age- and gender-specific INTs. Women age 45-75 years will receive the interventions for breast, colorectal, and cervical cancers screening. Men age 45-75 years will receive the intervention for colorectal cancer screening. Women age 21-49 years will receive the intervention for cervical cancer screening. The cognitive-behavioral INTs on age-gender specific cancers will range from 1-2 hours. The study team will utilize a digital flipchart that will cover each cancer's specific risk/protective factors, incidence, mortality, screening methods, and resources. The study team member delivering the INTs will function as a facilitator linking information with practical skills.

Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 45-75
• Average risk for breast cancer
• Never had a mammogram OR not had a mammogram within the past 2 years
• Residing in the Zuni Pueblo

You may not qualify if:

• Women with breast implants, pregnant, or breast feeding
• History of breast cancer
• Have new breast complaints such as lump or nipple discharge
• Men and women aged 45-75
• Average risk for colorectal cancer
• Never had a fecal occult blood test (FOBT), or fecal immunochemical test (FIT) or a colonoscopy OR not had a FOBT or FIT in the past year, OR no colonoscopy in the past 10 years
• Residing in the Zuni Pueblo
• History of colorectal cancer, total colectomy, adenomatous polyps, or inflammatory bowel disease
• Up-to-date with colorectal cancer screening
• Severe comorbidity
• Incarceration
• Family history of colorectal cancer
• Hospice/terminal care status
• Women aged 21-65
• Never had a cytology (Pap smear) OR had a Pap smear more than 3 years ago OR women aged 30-75, and never had screening with a combination of cytology and human papillomavirus testing OR no combination of testing in the past 5 years

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• University of New Mexico: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of New Mexico - Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Uterine Cervical Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Shiraz Mishra
• Organization: University of New Mexico Health Sciences Center

smishra@unm.edu

505-925-6085

Study Officials

• Shiraz I Mishra, MBBS, PhD

  University of New Mexico School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrollment numbers for Aims 3 and 4 are 96 and 281, respectively. The enrollment number n=131 is for Aim 8, INT, Pilot Test only.

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 6, 2020
• Study Start: June 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)