Patient navigation for colorectal cancer screening in deprived areas: the COLONAV cluster randomized controlled trial.

BACKGROUND: The objective of this study was to assess the effectiveness of a Patient Navigation Intervention targeting deprived patients for Colo-Rectal Cancer (CRC) screening participation. METHODS: A cluster randomized controlled trial was conducted in 5 districts. Peer Lay Patient Navigators were recruited to operate in deprived areas. Eligible participants had to be between 50 and 74 years old, live in these deprived areas and receive an invitation to the nationally organized Colo-Rectal Cancer (CRC) screening during the study period. The theory-driven navigation intervention was deployed for 18 months. A population Health Intervention Research assessment method was used to assess effectiveness and context interaction. The primary criterion was screening participation at 12 months. RESULTS: Twenty-four thousand two hundred eighty-one individuals were included inside 40 clusters. The increase in participation in the intervention group was estimated at 23%, (ORa = 1.23, CI95% [1.07-1.41], p = 0.003). For the subgroup of individuals who participated, the time delay to participating was reduced by 26% (ORa = 0.74, CI95% [0.57-0.96], p = 0.021). Main factors modulating the effect of the intervention were: closeness of navigator profiles to the targeted population, navigators' abilities to adapt their modus operandi, and facilitating attachment structure. CONCLUSION: The ColoNav Intervention succeeded in demonstrating its effectiveness, for CRC screening. Patient Navigation should be disseminate with broader health promotion goals in order to achieve equity in health care. TRIAL REGISTRATION: clinicaltrials.gov NCT02369757 24/02/2015.

ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol.

BACKGROUND: The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis. METHODS/DESIGN: The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months. DISCUSSION: The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases. TRIAL REGISTRATION: NCT02369757.

[Research and non-research. The values in the evaluation of epidemiological protocols]. / Recherche et non-recherche. Les valeurs à l'oeuvre dans l'évaluation des protocoles épidémiologiques.

BACKGROUND: Evaluation and ethical review of epidemiological research projects raises the problem of the limits between research and non-research. This ambiguous boundary reflects the status of this discipline at the crossroads between research and practical action. The question then is: in the field of health research, what gives data collection and analysis its quality of scientific activity? METHODS: A conceptual and empirical study has been conducted about the practices of epidemiological research evaluation, centred on the case of the French Consultative Committee for the data processing in health research (CCTIRS), which is a consultative board that permits the National commission for the personal data protection (CNIL) to take decision about health research protocols that process personal data. The study was realized from 2003 to 2006. RESULTS: It is shown that the evaluation of such research protocols processing personal data articulates intimately two kinds of criteria: methodology and relevance. By studying and characterizing the different kinds of protocols that are judged not to be "scientific research" (poor science, pseudo-science and non-science), it becomes possible to understand the motives that lead to distinguish between what is and what is not research in epidemiology. A special attention is given to two kinds of problematic cases: firstly, the case of conflict of interests into the protocols themselves (i.e. seeding trials or surveys); secondly, the problem of epidemiological registers and other databases which are not hypothesis-oriented. This last case leads to relate the conceptual frame of the committee with historical circumstances (the way which this discipline was introduced in France) and also mere epistemological considerations (the question of induction and generalizability). CONCLUSION: The activity of this committee illustrates a differentiated conception of what is research in epidemiology, influenced by explanatory analytical research paradigms. Finally, the field of epidemiological research appears to be structured by some values that appear through the elaboration and the application of the ethical and regulatory texts.