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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103451 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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
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
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]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria: Breast Cancer Screening Intervention
Exclusion Criteria: Breast Cancer Screening Intervention. Meeting at least one of the following criteria:
Inclusion Criteria: Colorectal Cancer Screening Intervention
Exclusion Criteria: Colorectal Cancer Screening Intervention. Meeting at least one of the following criteria:
Inclusion Criteria: Cervical Cancer Screening Intervention
Exclusion Criteria: Cervical Cancer Screening Intervention. Meeting at least one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiraz I Mishra, MBBS, PhD | University of New Mexico School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico - Cancer Center | Albuquerque | New Mexico | 87106 | United States |
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For Aim 3: Recruitment n=96, For Aim 4: Recruitment n=281, For Aim 8 (INT, Pilot Test), out of the 131 participants enrolled, 117 participants completed all Aim 8 study activities (pre- and post-INT surveys, educational and behavioral INT(s)). Preliminary data on these 117 participants are reported herein. The Zuni Pueblo's Tribal leadership has approved the findings for their wider dissemination. Aims 1, 2, 5, 6, and 7 were descriptive in nature, with no data collection.
For Aim 3 (Focus Groups, Descriptive): Enrollment n=96, For Aim 4 (Community Survey, Descriptive): Enrollment n=281 For Aim 8 (INT, Pilot Test), recruited 131 participants who had expressed interest to participate in the pilot test of the 3 cancer-specific INTs. The recruitment, followed by the baseline (pre-INT) survey, the 3 cancer-specific INTs, and the post-INT, were conducted between December 2022 and April 2023. Convenience sampling methods were used to recruit the participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 3, Focus Group, Descriptive: Cancer Control Needs | The investigators conducted 12 focus groups to document cancer control needs |
| FG001 | Aim 4, Community Survey, Descriptive | The investigators surveyed adults to document cancer control needs and existing cancer-screening practices |
| FG002 | Aim 8, INT, Pilot Test: Breast, Colorectal, and Cervical Cancer Screening | Breast, Colorectal, and Cervical Cancer Screening Interventions (Aim 8, INT, Pilot Test): The experimental arm comprised of adult men and women divided in three gender/age strata, based on gender/age-specific recommended cancer screening practices. Women age 50-75 years received the interventions for breast, colorectal, and cervical cancers screening. Men age 50-75 years received the intervention for colorectal cancer screening. Women age 21-49 years received the intervention for cervical cancer screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 3, Focus Groups, Descriptive: Cancer Control Needs | Trained focus group facilitators conducted the focus groups. Each session lasted approximately two hours. The facilitators used a semi-structured focus group guide to explore needs around cancer prevention and control, including knowledge, barriers and support, and communications. Conducted 11 focus groups with Community members (Community, N=85) and 1 focus group with providers (Provider, N=11) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The number analyzed in each row is based on the total number of participants (Community N=85 in 11 focus groups; Providers N=11 in one focus group) who took part in the focus group sessions | Posted | Count of Participants | Participants | 12 months |
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For Aim 3, t=12 months For Aim 4, t=7 months For Aim 8, t=8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aim 3, Focus Groups, Descriptive | Trained focus group facilitators conducted the focus groups. Each session lasted approximately two hours. The facilitators used a semi-structured focus group guide to explore needs around cancer prevention and control, including knowledge, barriers and support, and communications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shiraz Mishra | University of New Mexico Health Sciences Center | 505-925-6085 | smishra@unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2023 | Mar 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2018 | Mar 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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| BG001 | Aim 4, Community Survey, Descriptive: Cancer Control Needs | The study team conducted surveyed interested participants on their cancer screening practices. The surveys were age/gender specific. Women ages 50-75 were surveyed on breast, cervical, and colorectal cancers. Women aged 21-49 were surveyed on cervical cancer. Men aged 50-75 were surveyed on colorectal cancer |
| BG002 | Aim 8, INT, Pilot Test: Breast, Colorectal, and Cervical Cancer Screening | For Aim 8 (INT Pilot Test), the investigators will train Community Health Representatives (CHRs) in interactive group discussions techniques. CHRs will administer 1 session/week, lasting approximately 2 hours, and conducted among 12 men or women ages 21-75 per cluster. The CHRs will distribute the cancer-specific (i.e., breast, colorectal, and cervical) small media during the first session and refer to it during the course of the 4 sessions. During the sessions, the CHRs will function as a facilitator linking information with practical skills. At the end of the 4-week INT, participants will receive a voucher to present to a designated point-person at the health center who would schedule the screening for the age- and gender-specific cancers. Breast, Colorectal, and Cervical Cancer Screening Interventions (Aim 8, INT, Pilot Test): Women age 50-75 years will receive the interventions for breast, colorectal, and cervical cancers screening. Men age 50-75 years will receive the intervention for colorectal cancer screening. Women age 21-49 years will receive the intervention for cervical cancer screening. The 4-week interventions, delivered once a week, will consist of educational sessions that discuss cancer-specific information (i.e., breast, colorectal, and cervical cancer): breast (colorectal, cervical) cancer myths and facts, risk factors and symptoms, screening, and review/action plan. The educational sessions will be complemented by cancer-specific small media (brochure). |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Aim 4, Community Survey, Descriptive: Cancer Control Needs | Age/gender specific self-reported screening behaviors for breast, colorectum, and cervical cancers | The Number Analyzed in each row reflects the number of participants assessed, while the values reported in the data fields reflect the number of participants who Ever Had the respective screening examinations | Posted | Count of Participants | Participants | 7 months |
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| Primary | 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 | The number analyzed in each row is based on age/gender strata and the respective cancer screening test. Men and women age 45-75 were eligible for colorectal cancer screening test. Women age 45-75 were eligible for breast cancer screening test, women 21-75 were eligible for cervical cancer screening test. | Posted | Count of Participants | Participants | 8 months |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Aim 4, Community Survey, Descriptive | The study team conducted surveyed interested participants on their cancer screening practices. The surveys were age/gender specific. Women ages 50-75 were surveyed on breast, cervical, and colorectal cancers. Women aged 21-49 were surveyed on cervical cancer. Men aged 50-75 were surveyed on colorectal cancer | 0 | 281 | 0 | 281 | 0 | 281 |
| EG002 | Aim 8, INT, Pilot Test | 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. Breast, Colorectal, and Cervical Cancer Screening 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. | 0 | 117 | 0 | 117 | 0 | 117 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D012002 | Rectal Diseases |
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| Ever Had a Pap Test and/or HPV Test To Screen For Cervical Cancer, Women 21-75 years |
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| Colonoscopy, Men, 45-75 years (Aim 8, INT, Pilot Test) |
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| Colonoscopy, Women, 45-75 years (Aim 8, INT, Pilot Test) |
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| Mammogram, Women, 45-75 years (Aim 8, INT, Pilot Test) |
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| Pap Smear, Women, 45-75 years (Aim 8, INT, Pilot Test) |
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| Pap Smear, Women, 21-44 years (Aim 8, INT, Pilot Test) |
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