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Cancer, BreastNCT04259762

Enhancing Cancer Prevention and Control Pathways-Native Health Initiative

A study testing Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions in people with Cancer, Breast and Cancer, Colon, run by New Mexico Cancer Research Alliance at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Cancer, Breast, Cancer, Colon, Cancer, Cervix
What is being tested?
Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 31 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Exclusion Criteria: Breast Cancer Screening Intervention. Meeting at least one of the following criteria:
  • Women with breast implants, pregnant, or breast feeding
Show all 27Show fewer
  • History of breast cancer
  • Have new breast complaints such as lump or nipple discharge
  • Inclusion Criteria: Colorectal Cancer Screening Intervention
  • 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
  • Exclusion Criteria: Colorectal Cancer Screening Intervention. Meeting at least one of the following criteria:
  • 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
  • Residing in the Zuni Pueblo
  • Exclusion Criteria: Cervical Cancer Screening Intervention. Meeting at least one of the following criteria:
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico - Cancer Center

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

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.

Read the 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
Being tested
Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions
Keywords
breast neoplasm, colorectal neoplasm, cervical neoplasm, screening, behavioral interventions, American Indians
Medical subject headings
Breast Neoplasms, Colonic Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT04259762
Study groupRoleWhat they receive
Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer ScreeningExperimentalThe 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.
Receives: Other: Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

  2. Aim 4, Community Survey, Descriptive: Cancer Control Needs

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

    Measured: 7 months

  3. 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

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2020
  2. Study start1 Jun 2021
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04259762
Sponsor's protocol ID
18-264
Other IDs
P20GM103451
Status last verified
Mar 2025
First submitted
30 Jan 2020
Last updated
24 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Aim 8 (INT, Pilot Test): Breast, Colorectal, and Cervical Cancer Screening Cognitive-Behavioral Interventions in people with Cancer, Breast and Cancer, Colon, run by New Mexico Cancer Research Alliance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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