Enhancing Cancer Prevention and Control Pathways-Native Health Initiative

NCT ID: NCT04259762

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 508 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-10-31

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.

Detailed Description

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. Between 1990-2009, based on data from Contract Health Service Delivery Area Counties across the US, the mortality-to-incidence ratios for these cancers were significantly higher for American Indian/Alaska Natives compared to Whites (breast: 1.22, colorectal: 1.16, cervix: 1.36), indicating poorer survival. New Mexico (NM) AIs also experience substantial cancer disparities. Between 2010-2014, AIs compared to Whites had higher incidence (per 100,000) for cervical (7.9 vs. 6.9) and colorectal (male: 46.5 vs. 35.2; female: 29.2 vs. 28.2) cancers, and higher mortality for cervical (3.7 vs. 1.3) and colorectal (males only; 18.9 vs. 15.6) cancers. AIs were more likely to receive a late-stage (i.e., regional or distant) cancer diagnosis for all 3 screen detectable cancers. AIs have some of the lowest cancer screening rates compared with other racial/ethnic groups. In NM, AIs listed in the Indian Health Service (IHS) Albuquerque Area have substantially lower screening rates than the state's White population do. AIs had screening rates of: breast (58.5%, women ages 52-64), colorectal (41.9%, ages 50-75), and cervical (63.9%, women ages 24-64) cancers; whereas, screening rates for Whites were: breast (70.0%, ages 50-74), colorectal (69.2%, ages 50-75), and cervical (77.8%, women 21-65)

The overall objective is to develop and pilot test culturally and linguistically appropriate interventions to enhance age- and risk-appropriate breast, colorectal, and cervical cancer screening in concordance with the U.S. Preventive Services Task Force recommended guidelines

Aim 3 (Focus Groups, Descriptive): Qualitative documentation of perspectives on cancer control needs in the Zuni Pueblo

Protocol: Aim 3 (Focus Groups, Descriptive): Qualitative documentation of perspectives on cancer control needs in the Zuni Pueblo

1. Research Design: Focus groups that gather qualitative (descriptive) perspectives and insights from a small group of participants

2. Research Setting: Zuni Pueblo

3. Participant identification and sampling: Non-probability sampling

4. Procedures: The investigators will contact interested participants for focus group sessions

5. Primary Outcome: Knowledge about, barriers and support for, and communication about breast, cervix, and colorectal cancers

6. Data Analysis: Thematic analyses of transcripts of the focus group discussions

7. Sample Size Considerations: The investigators will enroll about 8-10 participants per focus group

Aim 4 (Community Survey, Descriptive): Documentation of perspectives on cancer control needs in the Zuni Pueblo

Protocol: Aim 4 (Community Survey, Descriptive): Documentation of perspectives on cancer control needs in the Zuni Pueblo

1. Research Design: Cross-sectional

2. Research Setting: Zuni Pueblo

3. Participant identification and sampling: The sampling strategy for the Community Survey includes random sampling of streets, strategic convenience sampling, and snowball sampling.

4. Procedures: The investigators will implement the Community Survey among interested and eligible participants. Participants will complete surveys documenting cancer control needs for breast, cervix, or colorectal cancers. Women aged 50-75 will be surveyed on breast, cervix, and colorectal cancers; women aged 21-49 will be surveyed on cervix cancer, and men aged 50-75 will be surveyed on colorectal cancer

5. Primary Outcome: Self-reported screening behaviors for breast, colorectal, and cervix cancers

6. Data Analysis: Descriptive analysis of survey data

7. Sample Size Considerations: The investigators will enroll about 300 participants

Aim 8 (INT, Pilot Test). Pilot test multilevel/multicomponent interventions on screening outcomes

Protocol. Aim 8 (INT, Pilot Test): Pilot Test Effectiveness of the Multilevel/Multicomponent Intervention [INT]

1. Research Design: One-group, pre-INT/post-INT

2. Research Setting: Zuni Pueblo

3. Randomization: Non-randomized, convenience sampling

4. Participant Identification and Sampling: The investigators will identify and contact participants who had previously expressed interest in participating in the pilot testing of any of the 3 cancer-specific INTs

5. Interventions: Educational and behavioral INTs on cancers of the breast, colorectal, and cervix

6. Procedures: The investigators will contact interested participants and redetermine eligibility. Eligible participants will complete baseline (pre-INT) and post-INT surveys about 6-8 months after receiving the INT(s). The surveys will be administered in-person or over the phone and will last approximately 20-30 minutes

7. Implementation of the INTs: The investigators could operationalize recommended strategies that may plausibly include strategies to: To increase community access, the investigators could: (a) Identify a point-person at the health center who will triage participants to and schedule them for appropriate screening(s). (b) Remind participants to complete their screening exam(s), offer assistance in scheduling a screening appointment and a ride to the health center. These strategies would reduce administrative barriers, navigate participants, and assist with transportation and in scheduling an appointment. To increase community demand, the investigators could consider: (a) Educational materials. (b) 1-on-1 education. (c) Cognitive-behavioral group education and incentives. To increase provider delivery, the investigators could: (a) Reduce health center-specific systemic barriers by identifying a point-person to promote and facilitate screening services

8. Baseline and Post-intervention Surveys: The investigators will collect data on demographics, self-reported receipt of a cancer-specific screening exam, self-reported scheduling of an appointment to obtain a cancer-specific screening exam, or self-reported attempt to make an appointment for a cancer-specific screening exam

9. Primary Outcome: 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 include FOBT/FIT/Colonoscopy for colorectal cancer, Pap smear for cervical cancer, or mammogram for breast cancer

10. Data Analysis: The investigators will compute the count of participants who self-reported receipt of a screening exam, scheduling an appointment for a screening exam, or attempt to make an appointment for a screening exam. These analyses will be presented by age/sex strata. Men age 45-75 for colorectal cancer screening; women 45-75 for breast, cervical, and colorectal cancer screening; and women 21-49 for cervical cancer screening

11. Sample Size Considerations: The investigators will enroll a total of 120 participants

Conditions

Cancer, Breast; Cancer, Colon; Cancer, Cervix

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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
• Residing in the Zuni Pueblo

Exclusion Criteria

• Women with breast implants, pregnant, or breast feeding
• History of breast cancer
• Have new breast complaints such as lump or nipple discharge

• 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

• History of total hysterectomy
• High risk for cervical cancer due to suppressed immune system (e.g., HIV infection, organ transplant, long-term steroid use)
• Women over age 65 who have had regular screenings with normal results

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shiraz I Mishra, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico School of Medicine

Locations

University of New Mexico - Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P20GM103451

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-264

Identifier Type: -

Identifier Source: org_study_id