Clinical trial · Interventional
Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)
Impact of Remote Familial Colorectal Cancer Assessment and Counseling
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project) is designed to determine whether a personalized telephone plus mailed print cancer risk assessment and behavior change counseling intervention is more effective than a targeted mailed print intervention in promoting risk appropriate screening in individuals with a family history of the disease. The project targets people residing in both rural and urban areas, allowing an examination of differential intervention effects with regard to place of residence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pamphlet intervention | Behavioral | — | UNRESOLVED |
| TeleCARE | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Telephone-delivered risk intervention
- description
- Participants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor.
- interventionNames
- Behavioral: TeleCARE
- type
- ACTIVE_COMPARATOR
- label
- Mailed pamphlet intervention group
- description
- Participants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening.
- interventionNames
- Behavioral: Pamphlet intervention
Primary outcomes (1)
- measure
- Colonoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Have at least one first-degree relative diagnosed with colorectal cancer (CRC) between the ages of 40-59, or one first-degree relative diagnosed with colorectal cancer at age 40 or older and an additional first-degree or second-degree relative diagnosed with colorectal cancer at age 40 or older. * If relative was diagnosed over age 50, participant must be 40-74 years old. * If relative was diagnosed at age 40-49, participant cannot be more than ten years younger than relative at first diagnosis (e.g., dx at 48, participant must be 38-74 years old). * Colorectal cancer cases of relatives recruited through the cancer registries of California, Colorado, Idaho, New Mexico, or Utah; Rocky Mountain Cancer Genetics Coalition sites of National Cancer Genetics Network in Colorado, New Mexico, or Utah; or Intermountain Health Care Exclusion Criteria: * Previous cancer diagnosis of any kind (except for non-melanoma skin cancers). * Has had a colonoscopy within the past five years. * Meets clinical criteria for Lynch syndrome or other polyposis syndromes. * Has had prior involvement in colorectal cancer-related clinical, behavioral or epidemiologic cancer familial research. * Mentally incompetent, incarcerated, hearing or visually impaired. * Unable to read and speak English fluently.
References
Publications (4)
- DERIVEDBrumbach BH, Birmingham WC, Boonyasiriwat W, Walters S, Kinney AY. Intervention Mediators in a Randomized Controlled Trial to Increase Colonoscopy Uptake Among Individuals at Increased Risk of Familial Colorectal Cancer. Ann Behav Med. 2017 Oct;51(5):694-706. doi: 10.1007/s12160-017-9893-1. PMID 28236077
- DERIVEDAnderson AE, Flores KG, Boonyasiriwat W, Gammon A, Kohlmann W, Birmingham WC, Schwartz MD, Samadder J, Boucher K, Kinney AY. Interest and informational preferences regarding genomic testing for modest increases in colorectal cancer risk. Public Health Genomics. 2014;17(1):48-60. doi: 10.1159/000356567. Epub 2014 Jan 14. PMID 24435063
- DERIVEDBoonyasiriwat W, Hung M, Hon SD, Tang P, Pappas LM, Burt RW, Schwartz MD, Stroup AM, Kinney AY. Intention to undergo colonoscopy screening among relatives of colorectal cancer cases: a theory-based model. Ann Behav Med. 2014 Jun;47(3):280-91. doi: 10.1007/s12160-013-9562-y. PMID 24307472
- DERIVEDSimmons RG, Lee YC, Stroup AM, Edwards SL, Rogers A, Johnson C, Wiggins CL, Hill DA, Cress RD, Lowery J, Walters ST, Jasperson K, Higginbotham JC, Williams MS, Burt RW, Schwartz MD, Kinney AY. Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial. Trials. 2013 Apr 30;14:116. doi: 10.1186/1745-6215-14-116. PMID 23782890