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Enhancing Prevention Pathways Toward Tribal Colorectal Health

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ClinicalTrials.gov Identifier: NCT02882620
Recruitment Status : Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shiraz I Mishra, University of New Mexico

Brief Summary:
Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and survival in the general U.S. population have been attributed to routine screening with prompt removal of polyps, early detection, and timely and appropriate treatment. American Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes and are significantly less likely than non-Hispanic Whites to receive recommended CRC screening. The purpose of this three-arm randomized controlled trial is to determine the efficacy of interventions designed to enhance CRC screening. The study also uses mixed methods to finalize the intervention and to determine promoters and barriers of screening. The study also conducts process evaluation to determine cost-effectiveness of the interventions, fidelity of study implementation, and to develop plans to sustain and scale-up the intervention model. The study will determine the efficacy of serially implemented interventions of graded intensity for increasing CRC screening using the fecal immunochemical test (FIT) in accordance to recommended guidelines among average risk American Indians (AIs) aged 50-75 residing on reservations in rural Southwestern U.S. Serial implementation refers to offering routine screening, irrespective of response to an earlier invitation, in concordance with guidelines which recommend annual FIT testing between ages 50-75. The FIT is most appropriate because it is an approved, high sensitivity fecal occult blood test and is available at Indian Health Service (IHS) and tribal health facilities where resources to provide screening colonoscopy are limited. The study is a collaborative effort between the Albuquerque Area Indian Health Board (100% Indian-owned and operated), six Pueblo Tribes in rural Southwestern U.S., and the University of New Mexico. Findings from this research could lead to an immediate increase in CRC screening and ultimately reduce CRC burden among AIs, thus addressing national and tribal priorities of reducing CRC disparities among AIs.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Behavioral: High Intensity (Group 1) Behavioral: Medium Intensity (Group 2) Behavioral: Reference Group (Group 3) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Enhancing Prevention Pathways Toward Tribal Colorectal Health
Study Start Date : October 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Intensity (Group 1)
The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
Behavioral: High Intensity (Group 1)
The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Experimental: Medium Intensity (Group 2)
The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
Behavioral: Medium Intensity (Group 2)
The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.

Experimental: Reference Group (Group 3)
The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
Behavioral: Reference Group (Group 3)
The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.




Primary Outcome Measures :
  1. Annual Completion of the FIT Kit [ Time Frame: The interventions are delivered over 3 12-month cycles. The primary outcome will be measured within 3 12-month periods. Cycle 1: T1-T12 months; Cycle 2: T13-T24 months; Cycle 3: T25-T36 months ]

Secondary Outcome Measures :
  1. Change in Knowledge [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess colorectal cancer related knowledge through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including colorectal cancer related knowledge about risk factors, symptoms, its screening tests, and recommended guidelines for screening. We will aggregate responses on the knowledge-related questions to provide an overall composite knowledge score at each of the time points (baseline and the three posttests). We will compute change in knowledge as the difference in the composite knowledge score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.

  2. Change in Attitudes [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess colorectal cancer related attitudes through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including colorectal cancer related attitudes about cancer, screening, and prevention. We will aggregate responses on the attitudes-related questions to provide an overall composite attitude score at each of the time points (baseline and the three posttests). We will compute change in attitudes as the difference in the composite attitude score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.

  3. Change in Perceived Control [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess perceived control through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including perceived control in getting colorectal cancer, control over its risk factors, and about screening. We will aggregate responses on the perceived control-related questions to provide an overall composite perceived control score at each of the time points (baseline and the three posttests). We will compute change in perceived control as the difference in the composite perceived control score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.

  4. Change in Perceived Susceptibility [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess perceived susceptibility through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including perceived susceptibility for colorectal cancer. We will aggregate responses on the perceived susceptibility-related questions to provide an overall composite perceived susceptibility score at each of the time points (baseline and the three posttests). We will compute change in perceived susceptibility as the difference in the composite perceived susceptibility score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.

  5. Change in Perceived Severity [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess perceived severity through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including perceived severity of colorectal cancer. We will aggregate responses on the perceived severity-related questions to provide an overall composite perceived severity score at each of the time points (baseline and the three posttests). We will compute change in perceived severity as the difference in the composite perceived severity score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.

  6. Change in Self-Efficacy [ Time Frame: Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months) ]
    We will assess self-efficacy through surveys administered at baseline and at three posttests. The surveys will be mailed 12 months apart. We will utilize validated questions from the NIH PROMIS instrument repository (http://www.nihpromis.org/), national surveys, and from our previous studies to measure the important theoretical constructs including self-efficacy with regarding to controlling risk factors and completing colorectal cancer screening. We will aggregate responses on the self-efficacy-related questions to provide an overall composite self-efficacy score at each of the time points (baseline and the three posttests). We will compute change in self-efficacy as the difference in the composite self-efficacy score at posttest 1 and at baseline, at posttest 2 and at posttest 1, and at posttest 3 and at posttest 2.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

A. Aim 1--Qualitative Research (Intervention Finalization)

Inclusion Criterion:

- Adult (50-75 years) AIs.

Exclusion criteria:

- None

Aim 1--Quantitative Research (Efficacy RCT)

Inclusion Criteria:

  • AIs at average-risk for CRC,
  • Not "up to date" with US Preventive Services Task Force (USPSTF) CRC screening guidelines (i.e., no guaiac fecal occult blood test [FOBT] or FIT in past year; no flexible sigmoidoscopy in past 5 years; no colonoscopy in past 10 years), and
  • Residing in one of the six Pueblo Tribes participating in the research.

Exclusion Criteria: meeting at least one of the following criteria:

  • History of CRC, total colectomy, adenomatous polyps, or history of inflammatory bowel disease,
  • Up-to-date with CRC screening,
  • Severe comorbidity,
  • No visit to IHS facilities in the past three years,
  • Incarceration,
  • Family history of CRC, or
  • Hospice/terminal care status.

C. Aim 2--Qualitative Research (Understanding Behavior Change Context)

Inclusion Criteria:

  • Participants who completed a FIT (Aim 1),
  • Participants who did not complete a FIT (Aim 1),
  • Navigators participating in the high intensity interventions (Aim 1),
  • Health care providers and medical directors of the IHS facilities participating in the study.

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882620


Contacts
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Contact: Shiraz I Mishra, MBBS, PhD 505-925-6085 smishra@salud.unm.edu
Contact: Kevin English, DrPH 505-962-2602 kenglish@aaihb.org

Locations
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United States, New Mexico
University of New Mexico School of Medicine Not yet recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Shiraz I Mishra, MBBS, PhD    505-925-6085    smishra@salud.unm.edu   
Sponsors and Collaborators
University of New Mexico
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Shiraz I Mishra, MBBS, PhD University of New Mexico School of Medicine
Principal Investigator: Kevin English, DrPH Albuquerque Area Indian Health Board

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Responsible Party: Shiraz I Mishra, Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02882620     History of Changes
Other Study ID Numbers: 14-363
R01CA192967 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shiraz I Mishra, University of New Mexico:
Colorectal neoplasm
Screening
Patient navigation
Randomized controlled trial
Cost-benefit analysis
Health behavior
Health equity
American Indians
Community-based participatory research
Fecal occult blood test

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases