Low-Income Women with Abnormal Breast Findings: Results of a Randomized Trial to Increase Rates of Diagnostic Resolution

Abstract

Background: Timely diagnostic resolution of abnormal breast findings represents a critical step in efforts to reduce breast cancer morbidity and mortality. Yet, follow-up rates among resource poor populations are not optimal. Efforts to mitigate this disparity are needed. We report results of a randomized trial assessing the effectiveness of a patient support and navigation intervention in increasing timely diagnostic resolution of abnormal breast findings among indigent women.Methods: Women (n = 1,708) diagnosed with a breast abnormality at two public hospitals were randomized to an intervention or control group. The intervention, delivered through telephone, involved one call from a professional health worker and multiple calls from a lay health worker. The outcome, timely diagnostic resolution, defined as receipt of a definitive diagnosis (malignant or benign) within 6 months of the index referral, was assessed through medical chart audit.Results: Intent-to-treat analyses revealed no significant effect of the intervention on timely diagnostic resolution. Diagnostic resolution rates were 55% and 56%, respectively, in the intervention and control arms. The significant predictors were method of abnormality identification (odds ratio = 1.50) and location of first scheduled appointment (odds ratio = 0.62).Conclusions: The intervention was not effective in creating change within the County health system. Achieving optimum diagnostic follow-up may require more intensive interventions than the one tested. In addition, system-level rather than patient-level interventions may hold more promise.Impact: There are no randomized trials reported in the literature testing interventions to increase diagnostic follow-up of breast abnormalities. Future research might test patient and system-level interventions that can be sustained beyond the study period. Cancer Epidemiol Biomarkers Prev; 19(8); 1927-36. ©2010 AACR.

Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review

“…Of 67 articles, thirty studies involved CBHWs for cancer prevention for specific cancer types (cervical, 28,32,33,35-39,41-44,49-52 breast, 26,27,31,33,36,37,[39][40][41]46,48,50,[53][54][55] colorectal, 29,30,34,36,45 and oral 47 ). Twenty six studies focused on cardiovascular disease (CVD), [56][57][58][59]62,64,67,73,80 , and key risk factors such as diabetes, 63,69,70,[76][77][78][79]81 and hypertension.…”

“…86 Forty-six (75%) studies employed individual randomization and 14 (23%) studies used cluster randomization. 29,33,34,36,39,47,48,54,55,58,62,63,68,82 The two most common types of comparison groups were less intensive intervention (n=17 [28%]), 27,35,36,38,40,46,53,57,58,62,[65][66][67]73,74,78,85 and usual care (n=16 [26%]) 31,32,37,41,44,47,51,55,60,64,71,72,76,77,83,86 or enhanced usual care (n=4 [7%]) 56,59,69,84 followed by wait-list control (n=7 [11%]), 42,45,[48][49][50]63,77 and attention control (n=3 [5%]). 39,52,82 Eight studies involved more than one comparison group (e.g., usual care and minimal intervention).…”

“…26,[28][29][30]61,68,75,80 34,36,42,62 Some studies relied solely on telephone contact for CBHW interventions. 27,37,53,74 …”

“…For example, only about half of the studies (n=34) discussed using a theoretical framework to develop the intervention or from which to select study outcomes. [26][27][28][29][31][32][33][34][35]39,[41][42][43][44]46,49,[53][54][55][62][63][64][65][73][74][75][76][77][78][79][80]84,85 In addition, less than one third of the selected studies discussed conducting a power analysis a priori (n=21) and less than half of studies (n=30) clearly described how they randomized study participants. Similarly, less than one in five studies discussed any type of blinding (i.e., the outcome assessor was aware of the status of the participant's group assignment) (n=13).…”

Patient Barriers to Follow-Up Care for Breast and Cervical Cancer Abnormalities

“…16,[27][28][29] Interpersonal factors associated with delays include inadequate communication or dissatisfaction with providers on test results or procedures. 27,28,30 System factors associated with delays include inconvenient appointment hours and long clinic waits; 29,31 having to seek care at larger hospitals; 32 first diagnostic appointment with radiology rather than a surgical consultancy; 32 and variations in healthcare services/procedures from clinic to clinic. 33 Increasingly, patient navigation programs have been used as a strategy to improve the timely receipt of needed healthcare services.…”