Trial Outcomes & Findings for Enhancing Cancer Prevention and Control Pathways-Native Health Initiative (NCT NCT04259762)
NCT ID: NCT04259762
Last Updated: 2025-09-24
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
508 participants
Primary outcome timeframe
12 months
Results posted on
2025-09-24
Participant Flow
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
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.
Participant milestones
| Measure |
Aim 3, Focus Group, Descriptive: Cancer Control Needs
The investigators conducted 12 focus groups to document cancer control needs
|
Aim 4, Community Survey, Descriptive
The investigators surveyed adults to document cancer control needs and existing cancer-screening practices
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
96
|
281
|
131
|
|
Overall Study
COMPLETED
|
96
|
281
|
117
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhancing Cancer Prevention and Control Pathways-Native Health Initiative
Baseline characteristics by cohort
| Measure |
Aim 4, Community Survey, Descriptive: Cancer Control Needs
n=281 Participants
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
|
Aim 3, Focus Groups, Descriptive: Cancer Control Needs
n=96 Participants
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)
|
Aim 8, INT, Pilot Test: Breast, Colorectal, and Cervical Cancer Screening
n=117 Participants
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).
|
Total
n=494 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
226 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
102 Participants
n=5 Participants
|
413 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
72 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
45 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
281 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
117 Participants
n=5 Participants
|
481 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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
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
Outcome measures
| Measure |
Aim 3, Focus Groups, Descriptive Cancer Control Needs
n=96 Participants
For Aim 3 (Focus Groups, Descriptive), the investigators will conduct focus groups among Zuni adults and healthcare providers practicing at the Zuni Community Health Center. Through the focus group discussions, the investigators will document cancer control needs in the Zuni Pueblo. The focus group discussion followed a semi-structured format, with stem questions followed up with probes, as needed.
|
|---|---|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Knowledge (Community): Variable knowledge and awareness regarding cancer and screening
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Knowledge (Community): Need information about cancers, screening tests, and prevention
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Knowledge (Community): Range of views regarding causality
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Knowledge (Community): Receptivity to preventive strategies
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Knowledge (Provider): Low screening due to individual-/system-level barriers
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Community): Systemic barriers
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Community): Confidentiality concerns
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Community): Benefits of supportive elements to promote better health
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Provider): Fear/denial, fatalism, and procrastination
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Provider): Social determinants of health
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Provider): Competing priorities and social conditions
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Barriers/Support (Provider): Systems-level barriers
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communication (Community): Discuss cancer screening with family
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communication (Community): Confidence, trust, gender concordance eases communications
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communication (Community): Cultural traditions, gender norms, privacy concern preclude communication
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communication (Community): Systems-level factors preclude healthcare discussions
|
85 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communications (Provider): Prioritize communication about cancer screening
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communications (Provider): Aware about screening but not going through it
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communications (Provider): Utilize culturally tailored counseling strategies
|
11 Participants
|
|
Aim 3, Focus Groups, Descriptive: Knowledge, Barriers and Support, and Communication About Breast, Cervix, and Colorectal Cancers
Communications (Provider): Use humor
|
11 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPopulation: 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
Age/gender specific self-reported screening behaviors for breast, colorectum, and cervical cancers
Outcome measures
| Measure |
Aim 3, Focus Groups, Descriptive Cancer Control Needs
n=281 Participants
For Aim 3 (Focus Groups, Descriptive), the investigators will conduct focus groups among Zuni adults and healthcare providers practicing at the Zuni Community Health Center. Through the focus group discussions, the investigators will document cancer control needs in the Zuni Pueblo. The focus group discussion followed a semi-structured format, with stem questions followed up with probes, as needed.
|
|---|---|
|
Aim 4, Community Survey, Descriptive: Cancer Control Needs
Ever Had A Mammogram To Screen For Breast Cancer, Women 50-75 years
|
95 Participants
|
|
Aim 4, Community Survey, Descriptive: Cancer Control Needs
Ever Completed an FOBT or Colonoscopy To Screen For Colorectal Cancer, Men and Women 50-75 years
|
92 Participants
|
|
Aim 4, Community Survey, Descriptive: Cancer Control Needs
Ever Had a Pap Test and/or HPV Test To Screen For Cervical Cancer, Women 21-75 years
|
129 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: 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.
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
Outcome measures
| Measure |
Aim 3, Focus Groups, Descriptive Cancer Control Needs
n=117 Participants
For Aim 3 (Focus Groups, Descriptive), the investigators will conduct focus groups among Zuni adults and healthcare providers practicing at the Zuni Community Health Center. Through the focus group discussions, the investigators will document cancer control needs in the Zuni Pueblo. The focus group discussion followed a semi-structured format, with stem questions followed up with probes, as needed.
|
|---|---|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Stool Test, Men, 45-75 years (Aim 8, INT, Pilot Test)
|
20 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Stool Test, Women, 45-75 years (Aim 8, INT, Pilot Test)
|
28 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Colonoscopy, Men, 45-75 years (Aim 8, INT, Pilot Test)
|
11 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Colonoscopy, Women, 45-75 years (Aim 8, INT, Pilot Test)
|
15 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Mammogram, Women, 45-75 years (Aim 8, INT, Pilot Test)
|
26 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Pap Smear, Women, 45-75 years (Aim 8, INT, Pilot Test)
|
23 Participants
|
|
Aim 8, INT, Pilot Test: Age/Gender-specific Breast, Colorectal, and Cervical Cancer Screening
Pap Smear, Women, 21-44 years (Aim 8, INT, Pilot Test)
|
21 Participants
|
Adverse Events
Aim 3, Focus Groups, Descriptive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 4, Community Survey, Descriptive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aim 8, INT, Pilot Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shiraz Mishra
University of New Mexico Health Sciences Center
Phone: 505-925-6085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place