The Implementation Guide is a resource for implementing this evidence-based program. It provides important information about the staffing and functions necessary for administering this program in the user's setting. Additionally, the steps needed to carry out the program, relevant program materials, and information for evaluating the program are included. The Implementation Guide can be viewed and downloaded in the Program Materials page.
Designed to increase colorectal cancer screening (CRC) among individuals with familial CRC risk, this intervention tailored to an individual’s risk and other personal factors provides an assessment; telephone counseling addressing family history, CRC risk, and screening; and a letter, action plan, and reminder card. The study showed an increase in colonoscopy screening.
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Colorectal cancer (CRC) is the third most common cancer diagnosed among men and women in the United States. Individuals with a family history of colorectal cancer are at increased risk of developing the disease. As many as one in five people who develop CRC have family members who have been affected by it.
The U.S. Preventive Services Task Force recommends that individuals with familial colon cancer begin CRC screening earlier than age 50, the age recommended for those at average risk. For example, individuals with a family history of two first-degree relatives diagnosed with CRC at any age or one first-degree relative diagnosed with CRC under age 60 should initiate CRC screening as early as age 40. (First-degree relatives are parents, siblings, and children.) Colorectal cancer cannot always be prevented, but early detection through screening can increase survival rates by treating the disease earlier in its development. Because treatment in the United States for CRC has improved in the past decades, more than one million people are colorectal cancer survivors. Interventions are needed to encourage CRC screening among individuals at increased risk due to family history.
Family Care (Colorectal Cancer Awareness and Risk Education) Project (FCARE) is a tailored, motivation-based intervention using telephone counseling and mailed printed materials for family members of individuals who have been diagnosed with CRC. FCARE aims to promote colonoscopy screening among people with familial CRC risk through education on the increased CRC risk associated with family history, the importance of routine screening to prevent CRC, and early detection to initiate CRC treatment. FCARE is guided by two theoretical models: The extended parallel process model (EPPM), a fear management model, is the basis for the content of the intervention, while the intervention's delivery style is based on motivational interviewing (MI). According to EPPM, individuals who perceive a threat (e.g., CRC) to be personally relevant and serious, who believe a recommended action (e.g., screening) can avert the threat, and who have self-efficacy to take the recommended action will take the action. MI is used to engage the participant in the process, promote self-efficacy, and encourage the participant to respond positively to the information on CRC risk.
A participant who meets the criteria for being at increased familial risk first participates in a baseline assessment collecting data on family history of CRC, colonoscopy screening, psychosocial characteristics and beliefs, and other factors. Second, the participant receives a packet by mail. The packet contains a letter providing an overview of the project; notification that the participant will be contacted by a cancer risk assessment specialist to schedule a telephone-based cancer risk assessment; an educational pamphlet about CRC targeted to individuals with familial risk; and a sealed envelope containing visual aids that are gender, age, and race specific and tailored to the participant's likelihood to engage in screening (based on information provided during the baseline assessment). The participant is asked not to open the sealed envelope until the phone session with the specialist. Next, the specialist initiates a phone session with the participant that requires an average of 39 minutes. During the call, the specialist and participant discuss the participant's family history and perceived CRC risk and severity, the effectiveness of CRC screening, and the participant's self-efficacy and plans to undergo screening. The specialist refers to the visual aids sent to the participant by mail. The discussion is tailored to the participant based on his or her family history of CRC, psychosocial factors and beliefs, CRC screening history and knowledge, health care access, social support, and barriers to screening. Specialists are certified genetic counselors trained in MI.
Immediately after the session, the participant receives a tailored letter summarizing the discussion and, if the participant expressed concern about the cost of screening, a colonoscopy financial resource letter. The participant also receives his or her action plan for obtaining a colonoscopy and a document showing his or her family cancer history, items that can be sent to the participant's physicians upon request. A month after the telephone session, the participant receives a reminder card by mail describing his or her action plan.
Community Preventive Services Task Force Finding
The total time to implement the intervention (i.e., preparing and mailing materials, conducting the telephone session, completing the action plan, mailing reminder cards) is approximately 70 minutes per participant.
The intervention can be implemented with adults who have a family history of CRC having either (1) a first-degree relative diagnosed with CRC before age 60 or (2) a first-degree relative diagnosed at age 60 or older plus an additional first- or second-degree relative diagnosed at any age. (Second-degree relatives include aunts/uncles, nieces/nephews, and grandparents.)
The program can be implemented in community and clinical settings.
The intervention requires certified genetic counselors trained in MI to deliver the telephone-based counseling sessions. In addition, required resources to implement the program include the following:
-- Baseline Questionnaire With Risk Behavior Diagnosis Scale
-- Visual Aids Example
-- Educational Pamphlet
-- Cancer Risk Assessment Specialist Protocol Quality Control Checklist
-- Pre-Intervention Patient Synopsis
-- Intervention Manual
-- Tailored Letter Template
-- Tailored Letter Example
-- Tailored Messages for Tailored Letter
-- Action Plan Reminder Card Example
-- 9-Month Follow-up Questionnaire
-- Resource Letter
-- Financial Resource List Example
-- Primary Care Provider/Clinic Release Form
-- Colorectal Cancer Screening Verification Letter
-- Colorectal Cancer Screening Verification Form
-- TELECARE Packet Cover Letter
For costs associated with this program, please contact the developer, Anita Y. Kinney. (See products page on the RTIPs website for developer contact information.)
About the Study
The study used a cluster-randomized design to compare the effect of FCARE and a targeted mailed intervention (i.e., educational pamphlet) on colonoscopy use. (FCARE was known by its previous name, Tele-Cancer Risk Assessment and Evaluation [TeleCARE], in the study.) Study participants were relatives of CRC patients, most of whom (97.1%) were identified from state cancer registries in California, Colorado, Idaho, New Mexico, and Utah.
Participants were 30‒74 years old (50 years old on average), were considered at an increased familial CRC risk warranting colonoscopy, and had received no colonoscopy within the past 5 years. Familial risk included having either (1) a first-degree relative diagnosed with CRC before age 60 or (2) a first-degree relative diagnosed at age 60 years or older plus an additional first- or second-degree relative diagnosed at any age. Exclusion criteria included being a member of a family with known hereditary cancer syndrome or a candidate for germ line mutation testing, having received counseling about familial cancer risk, having participated in a family cancer trial, and having any history of in situ or invasive cancer other than non-melanoma skin cancer. The study sample included 232 participants in the intervention group and 249 participants in the comparison group. Participants were 94.4% White, not of Hispanic or Latino origin; 3.5% Hispanic or Latino origin; and 2.1% other/unreported.
Comparison group participants received the same pamphlet as the intervention group. Intervention group participants who indicated that cost was a barrier during the telephone session received a financial resource letter within 1 week of the call and received it again 9 months later if they had not yet undergone a colonoscopy. Comparison group participants who indicated that cost was a barrier at any assessment point received the resource letter at 9 months if they had not yet undergone a colonoscopy.
Participants in the two study groups did not differ in baseline demographic or clinical characteristics. The primary outcome was receipt of a colonoscopy within 9 and 15 months of the intervention. Self-reported colonoscopies were verified through physician or clinic records if participants provided a medical release. Participants who self-reported a colonoscopy but did not provide a release for medical verification were counted as not screened. A 15-month follow-up questionnaire was mailed to participants who reported that they had not had a colonoscopy by the 9-month follow-up and to those with an unknown screening status. The intervention effect on receipt of colonoscopy was determined with generalized mixed logistic regression models to account for familial effect (i.e., types and numbers of family members with CRC). In addition, intent-to-treat analyses were used with all eligible participants who were randomly assigned, regardless of whether they withdrew or completed any of the follow-up surveys. The analyses conducted at 15 months also assessed the impact of the intervention relative to the comparison among individuals indicating that cost was a barrier to screening.
- A greater percentage of individuals in the intervention group received a colonoscopy at the 9-month follow-up compared with individuals in the comparison group (34.5% vs. 17.3%; p<.001).
- A greater percentage of individuals in the intervention group received a colonoscopy at the 15-month follow-up compared with individuals in the comparison group (42.7% vs. 24.1%; p<.001).
- Among participants who identified cost as a barrier to screening at baseline, 38.2% of those in the intervention group had a colonoscopy at 15 months compared with 23.7% of those in the comparison group (p=.0189). However, colonoscopy uptake at 15 months was not significantly increased by the addition of the cost resource letter, with no evidence of the effect of the letter differing based on group assignment (p=.50).
Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. (2014). Telehealth personalized cancer risk communication to motivate colonoscopy in relatives of patients with colorectal cancer: the family CARE Randomized controlled trial. Journal of Clinical Oncology, 32 (7), 654-662.
Steffen LE, Boucher KM, Damron BH, Pappas LM, Walters ST, Flores KG, Boonyasiriwat W, Vernon SW, Stroup AM, Schwartz MD, Edwards SL, Kohlmann WK, Lowery JT, Wiggins CL, Hill DA, Higginbotham JC, Burt R, Simmons RG, Kinney AY. (2015). Efficacy of a Telehealth Intervention on Colonoscopy Uptake When Cost Is a Barrier: The Family CARE Cluster Randomized Controlled Trial. Cancer Epidemiology, Biomarkers & Prevention, 24 (9), 1311-1318.
Birmingham WC, Hung M, Boonyasiriwat W, Kohlmann W, Walters ST, Burt RW, Stroup AM, Edwards SL, Schwartz MD, Lowery JT, Hill DA, Wiggins CL, Higginbotham JC, Tang P, Hon SD, Franklin JD, Vernon S, Kinney AY. (2015). Effectiveness of the extended parallel process model in promoting colorectal cancer screening. Psycho-oncology, 24 , 1265-1278.
Boonyasiriwat W, Hung M, Hon SD, Tang P, Pappas LM, Burt RW, Schwartz MD, Stroup AM, Kinney AY. (2014). Intention to undergo colonoscopy screening among relatives of colorectal cancer cases: a theory-based model. Annals Behavioral Medicine, 47 (3), 280-291.
Simmons, RG, Walters, ST, Pappas, LM, Boucher, KM, Boonyasiriwat, W, Gammon, A, Vernon, SW, Burt, RM, Stroup, AM, & Kinney, AY. (2014). Implementation of best practices regarding treatment fidelity in the Family Colorectal Cancer Awareness and Risk Education Randomized Controlled Trial. SAGE Open, 1-13.
Simmons 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. (2013). Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial. Trials, 14 (116), 1-12.
Pengchit W, Walters ST, Simmons RG, Kohlmann W, Burt RW, Schwartz MD, Kinney AY. (2011). Motivation-based intervention to promote colonoscopy screening: an integration of a fear management model and motivational interviewing. Journal of Health Psychology, 16 (8), 1187-1197.
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