HEALTH EDUCATION RESEARCH
Vol.30 no.4 2015 Pages 622–637 Advance Access published 28 May 2015
Tailored telephone counseling increases colorectal cancer screening Susan M. Rawl1,2*, Shannon M. Christy3,4, Patrick O. Monahan5,6, Yan Ding5,7, Connie Krier1, Victoria L. Champion1,2 and Douglas Rex5 1
*Correspondence to: S. M. Rawl. E-mail: [email protected] Received on September 2, 2014; accepted on April 28, 2015
Abstract To compare the efficacy of two interventions to promote colorectal cancer screening participation and forward stage movement of colorectal cancer screening adoption among first-degree relatives of individuals diagnosed with adenomatous polyps. One hundred fifty-eight first-degree relatives of individuals diagnosed with adenomatous polyps were randomly assigned to receive one of two interventions to promote colorectal cancer screening. Participants received either a tailored telephone counseling plus brochures intervention or a non-tailored print brochures intervention. Data were collected at baseline and 3 months post-baseline. Group differences and the effect of the interventions on adherence and stage movement for colorectal cancer screening were examined using t-tests, chi-square tests, and logistic regression. Individuals in the tailored telephone counseling plus brochures group were significantly more likely to complete colorectal cancer screening and to move forward on stage of change for fecal occult blood test, any colorectal cancer test stage and stage of the riskappropriate test compared with individuals in the non-tailored brochure group at 3 months post-baseline. A tailored telephone counseling plus brochures intervention successfully promoted forward stage movement and colorectal cancer screening adherence among first-degree
relatives of individuals diagnosed with adenomatous polyps.
Introduction Colorectal cancer (CRC) is a common disease in the United States with 136 830 new cases estimated in 2014 [1]. Approximately half of the expected 50 310 CRC deaths could be prevented if appropriate CRC screening was widely implemented [1–3]. Removal of adenomatous polyps through endoscopic screening has been found to decrease CRC incidence by 75–90% [4–8]. Increasing CRC screening participation among persons at increased risk is especially critical. When compared with the general population, first-degree relatives (FDRs) of persons diagnosed with colorectal adenomatous polyps (CAP) have been shown to have a 2-fold relative risk of developing CRC [9–13]. Indeed, FDRs of individuals diagnosed with CAP at age 50 or younger have a >4-fold relative risk of developing CRC [9]. Unfortunately, many patients are unaware of their FDRs increased risk of CRC as a result of their own CAP diagnosis [14]. Furthermore, few CAP patients communicate their diagnosis with FDRs or recommend screening to their relatives, who are at increased risk for CRC due to their family history of polyps [14]. This study is innovative because it tested two CRC screening interventions aimed to promoting CRC screening adherence as well as
ß The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]
doi:10.1093/her/cyv021
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
School of Nursing, Indiana University, 2Indiana University Simon Cancer Center, and 3Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN 46202, USA, 4Department of Psychology, VA Connecticut Healthcare System, West Haven, CT 06516, 5School of Medicine, 6School of Public Health, Indiana University, Indianapolis, IN 46202, USA and 7OptumInsight, Waltham, MA 02451, USA
TTC increases cancer screening
(i) Which intervention (TTC+ versus non-tailored mailed brochures) is more efficacious for promoting CRC screening adherence and forward stage movement at 3 months
post-baseline in FDRs of persons diagnosed with CAP? (ii) Which demographic characteristics moderate intervention efficacy in FDRs of individuals with CAP?
Materials and methods Theoretical framework The Transtheoretical Model (TTM) and the Health Belief Model (HBM) provided a conceptual foundation for the study at two levels: (i) as a framework guiding the overall study and (ii) for the development of the TTC+ intervention. The TTM describes behavior change as a dynamic process in which individuals move through discrete stages (i.e. Precontemplation, Contemplation, Preparation, Action and Maintenance) [27]. The HBM proposes that individuals will take action to prevent, screen for, or control a health condition if they: (i) consider themselves to be at risk for the condition; (ii) believe the condition to have serious consequences; (iii) believe that action will reduce either their susceptibility to or the severity of the condition; (iv) believe that the anticipated barriers to taking action are outweighed by the benefits; and (v) are confident in their ability to take action [28, 29]. The theoretical framework for the study is outlined in Figure 1.
Design For this randomized controlled trial (RCT), data were collected via structured telephone interviews at baseline and 3 months post-baseline. Participants were randomized to either the TTC+ or non-tailored brochure arm following baseline data collection. Randomization was stratified by age (i.e. 50–64 or 65+) and the participant’s relationship to the CAP patient (i.e. mother, father, sister, brother, daughter or son). Both intervention groups received two nontailored brochures—one produced by the American Cancer Society entitled ‘Colon Testing Can Save Your Life!’ and a second produced by the Centers for Disease Control entitled ‘Colorectal Cancer Screening Saves Lives.’ These brochures described 623
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
forward stage movement among FDRs of individuals diagnosed with CAP, a group at increased risk of developing CRC. Current guidelines for CRC screening are stratified by CRC risk [15]. Individuals are considered to be at ‘increased risk’ if they have: (i) a personal history of CRC or CAP; (ii) a personal history of inflammatory bowel disease; or (iii) a significant family history of CRC or CAP. Screening recommendations based upon a positive family history vary according to the number of relatives affected with CAP or CRC and their age(s) at time of diagnosis. People with a single FDR diagnosed with CRC or CAP at age 60 or older should be offered the screening options offered to those at average risk for CRC [i.e. annual fecal occult blood test (FOBT); fecal DNA testing; flexible sigmoidoscopy every 5 years; CT colonography every 5 years; double-contrast barium enema every 5 years; or colonoscopy every 10 years] starting at age 50 [16]. Persons who have an FDR diagnosed with CAP or CRC prior to age 60 or those with two or more affected FDRs should be screened with colonoscopy beginning at age 40 or 10 years earlier than the age at diagnosis of the youngest affected relative, whichever is earlier [15]. The efficacy of tailored telephone counseling (TTC) has been demonstrated in several studies designed to increase participation in cancer screening, particularly mammography [17–26]. However, to the authors’ knowledge, this is the first TTC trial aimed at individuals with a family history of CAP. The purposes of this trial were to: (i) compare the efficacy of a TTC plus brochures (TTC+) intervention versus non-tailored mailed brochures on CRC screening participation (primary outcome) and movement in stage of adoption for CRC screening among FDRs of persons diagnosed with CAP; and (ii) examine moderators of intervention efficacy. In addition, we assessed recall and satisfaction with the intervention for both groups. The specific research questions were:
S. M. Rawl et al. Background Variables
CRC & Screening Experience Family History Knowledge Provider Recommendation
Index Patient Characteristics Relationship to Study Participant Gender Age at Diagnosis
Health Beliefs Perceived Risk Perceived Benefits Perceived Barriers Self-Efficacy Stage of Adoption to Screen with: - FOBT - Sigmoidoscopy - Colonoscopy
Outcome Variables
Stages of Adoption to Screen with: FOBT Sigmoidoscopy Colonoscopy
CRC Screening Participation: Coverage (any test) Compliance (right test)
Tailored Telephone Counseling Intervention
Fig. 1. Theoretical framework. FOBT, fecal occult blood test.
CRC risk factors as well as the colon screening tests available. Individuals in the TTC+ intervention also received TTC. Figure 2 summarizes the flow of participants through the RCT.
Setting, participants and eligibility criteria A total of 158 FDRs of persons diagnosed within the past year with CAP at two large Midwestern hospitals were enrolled. Eligibility criteria included: (i) 50–80-years old; (ii) English-speaking; (iii) having no personal history of CRC; (iv) having not had an FOBT in the last 12 months, a flexible sigmoidoscopy in the last 5 years, or a colonoscopy in the last 10 years; and (v) having no medical conditions that prohibited CRC screening.
Recruitment Physician approval was obtained to contact 1930 CAP patients to ask them to refer their 624
potentially eligible FDRs to the study. We contacted 1365 patients, of whom 533 (39%) had no eligible FDRs to refer. Of the 832 who had potentially eligible relatives, 414 (50%) were willing to refer one or more relatives. Introductory letters that referenced the name and relationship of the relative who referred them were mailed to 559 FDRs (see Fig. 2). Letters included a toll-free telephone number to call to opt out for those who did not wish to be contacted. One week after letters were mailed, research staff telephoned all FDRs who did not decline. Trained recruiters reached 478 FDRs to explain the study, assess eligibility, obtain informed consent and answer questions. Of the 478 FDRs reached, 225 (47%) did not meet eligibility criteria. The most common reason for ineligibility was that individuals were up-to-date with CRC screening (n ¼ 213, 95%). Other reasons for
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
Demographics Age, Race, Gender, Education, Income, Employment, Marital Status, Health Insurance
Mediating/Intervening Variables
TTC increases cancer screening
Letters Mailed to Potentially Eligible FDRs (n=559)
Contacted by Phone to Assess Eligibility (n=478)
Recruitment and Enrollment
Excluded: Not meeting inclusion criteria (n=225; 47.1%)
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
Eligible FDRs (n=253)
Excluded: Declined to participate (n=95; 37.5%)
Baseline (T1) Interview & Randomized (n=158; 62.5%)
Allocation Tailored Telephone Counseling + Brochures (n=76) ♦ ♦
Nontailored Brochures (n=82) ♦
Received tailored intervention (n=75) Refused tailored intervention (n=1)
Received nontailored intervention (n=82)
Follow-Up Follow-up (3-month) Interview (n=73) Attrition (n=3)
Follow-up (3 month) Interview (n=80) Attrition: (n=2)
♦Lost to follow up (n=1) ♦Participant died (n=1) ♦Participant requested to withdraw (n=1)
♦Lost to follow up (n=2)
Analysis Analyzed (n=68)
Analyzed (n=77)
♦Excluded (n=5) FOBT in past 12 months at time of enrollment
♦Excluded (n=3) FOBT in past 12 months at time of enrollment
Fig. 2. Flow of FDR Participants through RCT. FDRs, first-degree relatives; FOBT, fecal occult blood test.
ineligibility included: personal history of CRC (n ¼ 5, 2%); 80 years of age (n ¼ 3, 1%); cognitively impaired (n ¼ 1;
Vol.30 no.4 2015 Pages 622–637 Advance Access published 28 May 2015
Tailored telephone counseling increases colorectal cancer screening Susan M. Rawl1,2*, Shannon M. Christy3,4, Patrick O. Monahan5,6, Yan Ding5,7, Connie Krier1, Victoria L. Champion1,2 and Douglas Rex5 1
*Correspondence to: S. M. Rawl. E-mail: [email protected] Received on September 2, 2014; accepted on April 28, 2015
Abstract To compare the efficacy of two interventions to promote colorectal cancer screening participation and forward stage movement of colorectal cancer screening adoption among first-degree relatives of individuals diagnosed with adenomatous polyps. One hundred fifty-eight first-degree relatives of individuals diagnosed with adenomatous polyps were randomly assigned to receive one of two interventions to promote colorectal cancer screening. Participants received either a tailored telephone counseling plus brochures intervention or a non-tailored print brochures intervention. Data were collected at baseline and 3 months post-baseline. Group differences and the effect of the interventions on adherence and stage movement for colorectal cancer screening were examined using t-tests, chi-square tests, and logistic regression. Individuals in the tailored telephone counseling plus brochures group were significantly more likely to complete colorectal cancer screening and to move forward on stage of change for fecal occult blood test, any colorectal cancer test stage and stage of the riskappropriate test compared with individuals in the non-tailored brochure group at 3 months post-baseline. A tailored telephone counseling plus brochures intervention successfully promoted forward stage movement and colorectal cancer screening adherence among first-degree
relatives of individuals diagnosed with adenomatous polyps.
Introduction Colorectal cancer (CRC) is a common disease in the United States with 136 830 new cases estimated in 2014 [1]. Approximately half of the expected 50 310 CRC deaths could be prevented if appropriate CRC screening was widely implemented [1–3]. Removal of adenomatous polyps through endoscopic screening has been found to decrease CRC incidence by 75–90% [4–8]. Increasing CRC screening participation among persons at increased risk is especially critical. When compared with the general population, first-degree relatives (FDRs) of persons diagnosed with colorectal adenomatous polyps (CAP) have been shown to have a 2-fold relative risk of developing CRC [9–13]. Indeed, FDRs of individuals diagnosed with CAP at age 50 or younger have a >4-fold relative risk of developing CRC [9]. Unfortunately, many patients are unaware of their FDRs increased risk of CRC as a result of their own CAP diagnosis [14]. Furthermore, few CAP patients communicate their diagnosis with FDRs or recommend screening to their relatives, who are at increased risk for CRC due to their family history of polyps [14]. This study is innovative because it tested two CRC screening interventions aimed to promoting CRC screening adherence as well as
ß The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]
doi:10.1093/her/cyv021
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
School of Nursing, Indiana University, 2Indiana University Simon Cancer Center, and 3Department of Psychology, Indiana University-Purdue University Indianapolis, Indianapolis, IN 46202, USA, 4Department of Psychology, VA Connecticut Healthcare System, West Haven, CT 06516, 5School of Medicine, 6School of Public Health, Indiana University, Indianapolis, IN 46202, USA and 7OptumInsight, Waltham, MA 02451, USA
TTC increases cancer screening
(i) Which intervention (TTC+ versus non-tailored mailed brochures) is more efficacious for promoting CRC screening adherence and forward stage movement at 3 months
post-baseline in FDRs of persons diagnosed with CAP? (ii) Which demographic characteristics moderate intervention efficacy in FDRs of individuals with CAP?
Materials and methods Theoretical framework The Transtheoretical Model (TTM) and the Health Belief Model (HBM) provided a conceptual foundation for the study at two levels: (i) as a framework guiding the overall study and (ii) for the development of the TTC+ intervention. The TTM describes behavior change as a dynamic process in which individuals move through discrete stages (i.e. Precontemplation, Contemplation, Preparation, Action and Maintenance) [27]. The HBM proposes that individuals will take action to prevent, screen for, or control a health condition if they: (i) consider themselves to be at risk for the condition; (ii) believe the condition to have serious consequences; (iii) believe that action will reduce either their susceptibility to or the severity of the condition; (iv) believe that the anticipated barriers to taking action are outweighed by the benefits; and (v) are confident in their ability to take action [28, 29]. The theoretical framework for the study is outlined in Figure 1.
Design For this randomized controlled trial (RCT), data were collected via structured telephone interviews at baseline and 3 months post-baseline. Participants were randomized to either the TTC+ or non-tailored brochure arm following baseline data collection. Randomization was stratified by age (i.e. 50–64 or 65+) and the participant’s relationship to the CAP patient (i.e. mother, father, sister, brother, daughter or son). Both intervention groups received two nontailored brochures—one produced by the American Cancer Society entitled ‘Colon Testing Can Save Your Life!’ and a second produced by the Centers for Disease Control entitled ‘Colorectal Cancer Screening Saves Lives.’ These brochures described 623
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
forward stage movement among FDRs of individuals diagnosed with CAP, a group at increased risk of developing CRC. Current guidelines for CRC screening are stratified by CRC risk [15]. Individuals are considered to be at ‘increased risk’ if they have: (i) a personal history of CRC or CAP; (ii) a personal history of inflammatory bowel disease; or (iii) a significant family history of CRC or CAP. Screening recommendations based upon a positive family history vary according to the number of relatives affected with CAP or CRC and their age(s) at time of diagnosis. People with a single FDR diagnosed with CRC or CAP at age 60 or older should be offered the screening options offered to those at average risk for CRC [i.e. annual fecal occult blood test (FOBT); fecal DNA testing; flexible sigmoidoscopy every 5 years; CT colonography every 5 years; double-contrast barium enema every 5 years; or colonoscopy every 10 years] starting at age 50 [16]. Persons who have an FDR diagnosed with CAP or CRC prior to age 60 or those with two or more affected FDRs should be screened with colonoscopy beginning at age 40 or 10 years earlier than the age at diagnosis of the youngest affected relative, whichever is earlier [15]. The efficacy of tailored telephone counseling (TTC) has been demonstrated in several studies designed to increase participation in cancer screening, particularly mammography [17–26]. However, to the authors’ knowledge, this is the first TTC trial aimed at individuals with a family history of CAP. The purposes of this trial were to: (i) compare the efficacy of a TTC plus brochures (TTC+) intervention versus non-tailored mailed brochures on CRC screening participation (primary outcome) and movement in stage of adoption for CRC screening among FDRs of persons diagnosed with CAP; and (ii) examine moderators of intervention efficacy. In addition, we assessed recall and satisfaction with the intervention for both groups. The specific research questions were:
S. M. Rawl et al. Background Variables
CRC & Screening Experience Family History Knowledge Provider Recommendation
Index Patient Characteristics Relationship to Study Participant Gender Age at Diagnosis
Health Beliefs Perceived Risk Perceived Benefits Perceived Barriers Self-Efficacy Stage of Adoption to Screen with: - FOBT - Sigmoidoscopy - Colonoscopy
Outcome Variables
Stages of Adoption to Screen with: FOBT Sigmoidoscopy Colonoscopy
CRC Screening Participation: Coverage (any test) Compliance (right test)
Tailored Telephone Counseling Intervention
Fig. 1. Theoretical framework. FOBT, fecal occult blood test.
CRC risk factors as well as the colon screening tests available. Individuals in the TTC+ intervention also received TTC. Figure 2 summarizes the flow of participants through the RCT.
Setting, participants and eligibility criteria A total of 158 FDRs of persons diagnosed within the past year with CAP at two large Midwestern hospitals were enrolled. Eligibility criteria included: (i) 50–80-years old; (ii) English-speaking; (iii) having no personal history of CRC; (iv) having not had an FOBT in the last 12 months, a flexible sigmoidoscopy in the last 5 years, or a colonoscopy in the last 10 years; and (v) having no medical conditions that prohibited CRC screening.
Recruitment Physician approval was obtained to contact 1930 CAP patients to ask them to refer their 624
potentially eligible FDRs to the study. We contacted 1365 patients, of whom 533 (39%) had no eligible FDRs to refer. Of the 832 who had potentially eligible relatives, 414 (50%) were willing to refer one or more relatives. Introductory letters that referenced the name and relationship of the relative who referred them were mailed to 559 FDRs (see Fig. 2). Letters included a toll-free telephone number to call to opt out for those who did not wish to be contacted. One week after letters were mailed, research staff telephoned all FDRs who did not decline. Trained recruiters reached 478 FDRs to explain the study, assess eligibility, obtain informed consent and answer questions. Of the 478 FDRs reached, 225 (47%) did not meet eligibility criteria. The most common reason for ineligibility was that individuals were up-to-date with CRC screening (n ¼ 213, 95%). Other reasons for
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
Demographics Age, Race, Gender, Education, Income, Employment, Marital Status, Health Insurance
Mediating/Intervening Variables
TTC increases cancer screening
Letters Mailed to Potentially Eligible FDRs (n=559)
Contacted by Phone to Assess Eligibility (n=478)
Recruitment and Enrollment
Excluded: Not meeting inclusion criteria (n=225; 47.1%)
Downloaded from http://her.oxfordjournals.org/ at Florida International University on November 14, 2015
Eligible FDRs (n=253)
Excluded: Declined to participate (n=95; 37.5%)
Baseline (T1) Interview & Randomized (n=158; 62.5%)
Allocation Tailored Telephone Counseling + Brochures (n=76) ♦ ♦
Nontailored Brochures (n=82) ♦
Received tailored intervention (n=75) Refused tailored intervention (n=1)
Received nontailored intervention (n=82)
Follow-Up Follow-up (3-month) Interview (n=73) Attrition (n=3)
Follow-up (3 month) Interview (n=80) Attrition: (n=2)
♦Lost to follow up (n=1) ♦Participant died (n=1) ♦Participant requested to withdraw (n=1)
♦Lost to follow up (n=2)
Analysis Analyzed (n=68)
Analyzed (n=77)
♦Excluded (n=5) FOBT in past 12 months at time of enrollment
♦Excluded (n=3) FOBT in past 12 months at time of enrollment
Fig. 2. Flow of FDR Participants through RCT. FDRs, first-degree relatives; FOBT, fecal occult blood test.
ineligibility included: personal history of CRC (n ¼ 5, 2%); 80 years of age (n ¼ 3, 1%); cognitively impaired (n ¼ 1;
