Despite the overall decline in cervical cancer, there is a large disparity between disease-related incidence and mortality rates for African Americans (AA) and Latinas compared to Caucasians. Adherence to diagnostic colposcopy and follow-up regimens is crucial after an abnormal Pap smear result indicative of oncogenic HPV (approximately 75 percent of abnormalities), since early detection and medical management can prevent invasive cervical cancer. However, rates of adherence to initial diagnostic colposcopy and subsequent medical recommendations remain low among low-income minority populations. Hence, there is a need to develop and evaluate the efficacy of culturally- sensitive, transportable health communication protocols to facilitate adherence over time. Guided by the Cognitive-Social Health Information Processing (C-SHIP) model, this randomized controlled trial aims to conduct a head-to-head comparison of a tailored counseling intervention protocol, delivered through either telephone or mail-home print, designed to assess and address cognitive- affective barriers to adherence among low-income AAs and Latinas prior to the initial diagnostic colposcopy appointment. Patients (N=730) will receive a barriers assessment and will be randomly assigned to: 1) standard care (SC; notification letter plus telephone appointment confirmation); 2) telephone barriers counseling (CAB-T; SC plus tailored Cognitive-Affective Barriers Counseling delivered by phone); or 3) print barriers counseling (CAB-P; SC plus tailored Cognitive-Affective Barriers Print materials delivered via mail). Additional aims are to explore the cognitive-affective mediators of intervention impact and the moderating role of attentional style on the individual's cognitive-affective processing profile. Outcome measures will assess adherence to initial colposcopy and to follow-up management recommendations over the 15-month cervical surveillance cycle, cognitive-affective processes (risk-related knowledge/perceptions, fatalism, motivation to adhere, intrusive/avoidant ideation, health-related planning) and intervention cost-effectiveness. Psychosocial assessments will be conducted by telephone at baseline (2-4 weeks pre-colposcopy), and at 1-week, 9-months, and 15-months post-index colposcopy. A dissemination plan will be developed from study outcomes data, the cost-effectiveness analysis, patient intervention evaluations, and input from a Community Advisory Committee and on-site staff. The study brings together two key strengths, expertise in: 1) cervical cancer risk assessment; and 2) the design and analysis of transportable tailored counseling protocols targeted to underserved at-risk groups. Findings are relevant not only to the management of precancerous cervical disease, but will also lay the groundwork for counseling protocols that can be readily disseminated into routine care to increase adherence to medical regimens, with a view to ultimately reducing the disparity in disease rates among underserved populations.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
1R01CA104979-01A1
Application #
6821869
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Chu, Kenneth C
Project Start
2004-09-15
Project End
2009-08-31
Budget Start
2004-09-15
Budget End
2005-08-31
Support Year
1
Fiscal Year
2004
Total Cost
$553,522
Indirect Cost
Name
Fox Chase Cancer Center
Department
Type
DUNS #
073724262
City
Philadelphia
State
PA
Country
United States
Zip Code
19111
Miller, Suzanne M; Tagai, Erin K; Wen, Kuang-Yi et al. (2017) Predictors of adherence to follow-up recommendations after an abnormal Pap smear among underserved inner-city women. Patient Educ Couns 100:1353-1359
Roussi, Pagona; Miller, Suzanne M; Giri, Veda N et al. (2016) Effects of a randomized trial comparing standard and enhanced counseling for men at high risk of prostate cancer as a function of race and monitoring style. J Health Psychol :1359105316671188
Igwe, Elena; Woodburn, Julie; Davolos, Jacyln et al. (2016) Patient perceptions and willingness to participate in clinical trials. Gynecol Oncol 142:520-4
Lee, Minsun; Miller, Suzanne M; Wen, Kuang-Yi et al. (2015) Cognitive-behavioral intervention to promote smoking cessation for pregnant and postpartum inner city women. J Behav Med 38:932-43
Roussi, Pagona; Miller, Suzanne M (2014) Monitoring style of coping with cancer related threats: a review of the literature. J Behav Med 37:931-54
Hui, Siu-Kuen Azor; Miller, Suzanne M; Wen, Kuang-Yi et al. (2014) Psychosocial barriers to follow-up adherence after an abnormal cervical cytology test result among low-income, inner-city women. J Prim Care Community Health 5:234-41
Miller, Suzanne M; Hui, Siu-kuen Azor; Wen, Kuang-Yi et al. (2013) Tailored telephone counseling to improve adherence to follow-up regimens after an abnormal pap smear among minority, underserved women. Patient Educ Couns 93:488-95
Buzaglo, Joanne S; Miller, Suzanne M; Kendall, Jeffery et al. (2013) Evaluation of the efficacy and usability of NCI's Facing Forward booklet in the cancer community setting. J Cancer Surviv 7:63-73
Wen, Kuang-Yi; Miller, Suzanne M; Lazev, Amy et al. (2012) Predictors of smoking cessation counseling adherence in a socioeconomically disadvantaged sample of pregnant women. J Health Care Poor Underserved 23:1222-38
Roussi, Pagona; Sherman, Kerry A; Miller, Suzanne M et al. (2011) Identification of cognitive profiles among women considering BRCA1/2 testing through the utilisation of cluster analytic techniques. Psychol Health 26:1327-43

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