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Randomized Controlled Trial
. 2018 Jun 5;18(1):413.
doi: 10.1186/s12913-018-3226-3.

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study

Ralf Porzig  1 , Sina Neugebauer  2 , Thomas Heckmann  3 , Daniela Adolf  4 , Peter Kaskel  2 , Ursula G Froster  3
Affiliations
Randomized Controlled Trial

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study

Ralf Porzig et al. BMC Health Serv Res. .

Abstract

Background: Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany.

Methods: The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed.

Discussion: For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence.

Trial registration: The study has been registered under DRKS00013199 in the German Clinical Trials Register.

Keywords: Disease costs; Disease management; Healthcare competence; Healthcare research; Oncology; Patient-relevant results; Psychosocial care; Treatment outcomes.

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Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of the Saxony State Medical Board approved the study material at its meetings on August 21, 2017 and September 11, 2017 under file number EK-BR-51/17–1. This ethical approval covers all of the study sites that are used in this study. All patients provided informed consent prior to participation.

Competing interests

The study is funded by MSD Sharp & Dohme GmbH. SN and PK are full-time employees at MSD SHARP & DOHME GMBH, Lindenplatz 1, 85,540 Haar, Germany. RP, TH, DA, and UF declare no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study procedure. The figure shows the study flow from informed consent to randomization, intervention and analysis. Green arrows show personal contacts, black arrows any contact, dashed arrows optional contacts between study participants. M = month, R = randomization, t = time point#. Box colors: Green = patients, purple = physicians, blue = cancer patient navigators, orange = family members
See this image and copyright information in PMC

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