Colorectal CancerFamily CARENCT01274143
Family Colorectal Cancer Awareness and Risk Education Project (Family CARE Project)
A study testing TeleCARE and Pamphlet intervention in people with Colorectal Cancer, run by University of Utah at 8 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TeleCARE and Pamphlet intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2008to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Colorado Cancer Center
Aurora, Colorado, 80045
Cancer Data Registry of Idaho
Boise, Idaho, 83701
Colorado Central Cancer Registry
Denver, Colorado, 80246
California Cancer Registry
Sacramento, California, 95825
Intermountain Health Care
Salt Lake City, Utah, 84111
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Utah Cancer Registry
Salt Lake City, Utah, 84112
About this study
Official title: Impact of Remote Familial Colorectal Cancer Assessment and Counseling
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.
Read the detailed description
The rate of adherence to regular colonoscopy screening (CS) among members of families at increased risk for colorectal cancer (CRC) is far below recommended levels. Persons who live in rural areas of the United States exhibit lower CRC screening rates than their urban counterparts. Although the detection of familial predisposition to cancer begins with an accurate family medical history, data indicate that many patients do not receive adequate familial cancer risk assessment from their primary care providers. This suggests that familial risk is largely unrecognized which may lead to inadequate risk stratification, lack of risk notification, appropriate risk counseling, suboptimal cancer screening and preventable deaths. Because of geographic and system-level barriers, special efforts are needed to improve access to personalized risk communication and adherence to CRC screening to rural and other geographically underserved populations at increased risk for CRC. In the proposed study, we will evaluate a novel telephone-based, theory-guided personalized risk communication intervention that combines a familial CRC risk assessment and behavioral counseling with tailored messages. The key hypothesis guiding this study is that a multifaceted personalized risk communication intervention will improve CS at a significantly higher rate than a mailed targeted print intervention.
Our integrative study model specifies important theoretical mechanisms that can contribute to increased use of CS among persons at increased risk. We will enroll 438 adult men and women between the ages of 30-74 who are considered at increased risk of familial CRC into this 2-group randomized trial. The primary aim of this study is to compare colonoscopy use among participants in the two groups. Secondary aims are to compare the two groups with regard to cognitive and emotional outcomes and explore the underlying mechanisms through which the interventions have an impact on colonoscopy behavior. Sociodemographic, clinical, behavioral and psychosocial measures will be collected from participants at baseline, and 1 month, 9 months, and 15 months following the intervention. Self-reported colonoscopy is verified with medical records.
The study's findings will have both theoretical, as well as practical significance. Our findings will help to influence the selection and dissemination of effective outreach approaches to improve CRC screening in populations at increased risk for the disease. These results have broad applicability to understanding responses to personalized risk communication interventions for other diseases as well. Findings will also broaden our understanding of the underlying theoretical mechanisms of how remote cancer risk communications lead to improvements in cancer screening among geographically underserved populations if such intervention effects are observed.
In addition to studying the intervention effects in rural areas, we will enroll participants in urban areas. These enhancements to our population-based randomized behavioral trial will provide us with an unprecedented opportunity to assess reach and determine if there are differential intervention effects (i.e., efficacy) with regard to place of residence (rurality vs. urbanicity.)
- Conditions
- Colorectal Cancer
- Being tested
- TeleCARE, Pamphlet intervention
- Keywords
- Colorectal, Cancer, Colon, Rectal, Behavioral Intervention, Screening, Motivational Interviewing, Extended Parallel Process Model, Implementation Intentions, Family CARE
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleCAREBehavioural
Personalized telephone-delivered cancer risk assessment.
Pamphlet interventionBehavioural
Mailed pamphlet about familial colorectal cancer risk and screening.
| Study group | Role | What they receive |
|---|---|---|
| Telephone-delivered risk intervention | Active comparator | Participants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor. Receives: Behavioral: TeleCARE |
| Mailed pamphlet intervention group | Active comparator | Participants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening. Receives: Behavioral: Pamphlet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy
The primary outcome is colonoscopy. Medical record verification of self-reported colonoscopy is performed.
Measured: 9 month follow-up
Secondary outcomes (6)
Fecal occult blood test (FOBT)/Fecal Immunochemical Test (FIT)
Fecal occult blood test(FOBT) following the intervention. Medical confirmation of self-reported FOBT/FIT is performed.
Measured: Baseline, 1 month, 9 month, and 15 month follow-up
Perceived Control
The Perceived Personal Control Scale is an integrative outcome that encompasses the broad spectrum of health risk communication and informed decision-making. This validated scale is a 9-item measure representing three dimensions of control participants believe they have regarding family history of colorectal cancer (CRC): cognitive-interpretive, decisional, and behavioral. A 5-point Likert-style response format is used ranging from very little control to very high control. A total scale score is calculated by summing the items.
Measured: Baseline, 1 month and 9 month follow-up
Perceived Risk
A 4-item scale with established construct and predictive validity with regard to cancer screening will assess participants' subjective perceived risk for developing colorectal cancer. Responses are measured on a five-point Likert scale ranging from very small to very large.
Measured: Baseline, 1 month and 9 month follow-up
Psychological distress
Generalized psychological distress will be operationalized as state anxiety and we will use the State Subscale of the State Trait Anxiety Inventory. We will also measure cancer-specific distress with the Impact of Event Scale. The stressor in this study is having a family history of colorectal cancer.
Measured: Baseline, 1 month and 9 month follow-up
Knowledge
The Colorectal Cancer Knowledge Survey is a validated 12-item scale that assesses colorectal cancer screening knowledge, colorectal cancer risk factors (including family history) and CRC symptoms. The questionnaire consists of true/false with a possible range of scores of 0-12. FOBT items will be substituted with colonoscopy.
Measured: Baseline, 1 month and 9 month follow-up
Decisional Conflict
Participants are asked to evaluate whether or not they feel confident in their decision to receive or not receive CRC screening. Assessment following the intervention will determine whether the decisional conflict has been resolved and whether or not that resolution results in colonoscopy uptake.
Measured: Baseline, 1 month and 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMay 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Anita Kinney, University of Utah
- Investigators
- Anita Y Kinney, Ph.D., R.N., Principal investigator, Huntsman Cancer Institute and University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274143
- Sponsor's protocol ID
- IRB_00017894
- Other IDs
- 7R01CA125194-06
- Acronym
- Family CARE
- Status last verified
- May 2015
- First submitted
- 10 Dec 2010
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brumbach 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.
PubMed 28236077Anderson 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.
PubMed 24435063Boonyasiriwat 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.
PubMed 24307472Simmons 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.
PubMed 23782890
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Remote Familial Colorectal Cancer Assessment and Counseling
- ClinicalTrials.gov ID
- NCT01274143
- Acronym / sponsor ID
- Family CARE / IRB_00017894
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, Cancer, Colon, Rectal, Behavioral Intervention, Screening, Motivational Interviewing, Extended Parallel Process Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The rate of adherence to regular colonoscopy screening (CS) among members of families at increased risk for colorectal cancer (CRC) is far below recommended levels. Persons who live in rural areas of the United States exhibit lower CRC screening rates than their urban counterparts. Although the detection of familial predisposition to cancer begins with an accurate family medical history, data indicate that many patients do not receive adequate familial cancer risk assessment from their primary care providers. This suggests that familial risk is largely unrecognized which may lead to inadequate risk stratification, lack of risk notification, appropriate risk counseling, suboptimal cancer screening and preventable deaths. Because of geographic and system-level barriers, special efforts are needed to improve access to personalized risk communication and adherence to CRC screening to rural and other geographically underserved populations at increased risk for CRC. In the proposed study, we will evaluate a novel telephone-based, theory-guided personalized risk communication intervention that combines a familial CRC risk assessment and behavioral counseling with tailored messages. The key hypothesis guiding this study is that a multifaceted personalized risk communication intervention will improve CS at a significantly higher rate than a mailed targeted print intervention.
Our integrative study model specifies important theoretical mechanisms that can contribute to increased use of CS among persons at increased risk. We will enroll 438 adult men and women between the ages of 30-74 who are considered at increased risk of familial CRC into this 2-group randomized trial. The primary aim of this study is to compare colonoscopy use among participants in the two groups. Secondary aims are to compare the two groups with regard to cognitive and emotional outcomes and explore the underlying mechanisms through which the interventions have an impact on colonoscopy behavior. Sociodemographic, clinical, behavioral and psychosocial measures will be collected from participants at baseline, and 1 month, 9 months, and 15 months following the intervention. Self-reported colonoscopy is verified with medical records.
The study's findings will have both theoretical, as well as practical significance. Our findings will help to influence the selection and dissemination of effective outreach approaches to improve CRC screening in populations at increased risk for the disease. These results have broad applicability to understanding responses to personalized risk communication interventions for other diseases as well. Findings will also broaden our understanding of the underlying theoretical mechanisms of how remote cancer risk communications lead to improvements in cancer screening among geographically underserved populations if such intervention effects are observed.
In addition to studying the intervention effects in rural areas, we will enroll participants in urban areas. These enhancements to our population-based randomized behavioral trial will provide us with an unprecedented opportunity to assess reach and determine if there are differential intervention effects (i.e., efficacy) with regard to place of residence (rurality vs. urbanicity.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-delivered risk intervention | Active comparator | Behavioral: TeleCAREParticipants in this arm receive a personalized telephone-risk assessment intervention provided by a trained cancer risk counselor. |
| Mailed pamphlet intervention group | Active comparator | Behavioral: Pamphlet interventionParticipants in this group receive a mailed pamphlet containing information about familial colorectal cancer risk and screening. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleCAREPersonalized telephone-delivered cancer risk assessment. | Behavioural | Telephone-delivered risk intervention |
| Pamphlet interventionMailed pamphlet about familial colorectal cancer risk and screening. | Behavioural | Mailed pamphlet intervention group |
Primary outcome
Colonoscopy
Time frame: 9 month follow-up
The primary outcome is colonoscopy. Medical record verification of self-reported colonoscopy is performed.
6 secondary outcomes
Fecal occult blood test (FOBT)/Fecal Immunochemical Test (FIT)
Time frame: Baseline, 1 month, 9 month, and 15 month follow-up
Perceived Control
Time frame: Baseline, 1 month and 9 month follow-up
Perceived Risk
Time frame: Baseline, 1 month and 9 month follow-up
Psychological distress
Time frame: Baseline, 1 month and 9 month follow-up
Knowledge
Time frame: Baseline, 1 month and 9 month follow-up
Decisional Conflict
Time frame: Baseline, 1 month and 9 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Derived from this study: PubMed 28236077Brumbach 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.
- Derived from this study: PubMed 24435063Anderson 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.
- Derived from this study: PubMed 24307472Boonyasiriwat 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.
- Derived from this study: PubMed 23782890Simmons 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.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Y Kinney, Ph.D., R.N. principal investigator
Huntsman Cancer Institute and University of Utah
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleCARE and Pamphlet intervention in people with Colorectal Cancer, run by University of Utah at 8 sites 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 4 inclusion and 6 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Colonoscopy (time frame: 9 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274143, which also lists 4 linked publications.
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 8 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.