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BMC Health Services Research
Published in: BMC Health Services Research 1/2017

Open Access 01-12-2017 | Study protocol

Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial

Authors: Chloé Gervès-Pinquié, Fatima Daumas-Yatim, Benoît Lalloué, Anne Girault, Marie Ferrua, Aude Fourcade, François Lemare, Mario Dipalma, Etienne Minvielle

Published in: BMC Health Services Research | Issue 1/2017

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Abstract

Background

The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program’s potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

Methods/design

We are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including tumor response, survival, toxic side effects, patient quality of life and patient experience An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health. care resources’ used. A parallel process evaluation will be conducted to describe implementation of the intervention.

Discussion

If the CAPRI program does improve treatment delivery, the evidence on its economic impact will offer important knowledge for health decision-makers, helping develop new follow-up services for patients receiving oral chemotherapy and/or targeted therapy. The process evaluation will determine the best conditions in which such a program might be implemented.

Trial registration

NCT 02828462. Registered 29 June 2016.
Literature
1.
Thanki K, Gangwal RP, Sangamwar AT, Jain S. Oral delivery of anticancer drugs: Challenges and opportunities. J Controlled Release. 2013;170:15–40.CrossRef
2.
Agboola S, Flanagan C, Searl M, Elfiky A, Kvedar J, Jethwani K. Improving outcomes in cancer patients on oral anti-cancer medications using a novel mobile phone-based intervention: study design of a randomized controlled trial. JMIR Res Protoc. 2014;3:e79.CrossRefPubMedPubMedCentral
3.
Spoelstra SL, Given BA, Given CW, Grant M. Policy Implications of Oral Agents. Semin Oncol Nurs. 2011;27:161–5.CrossRefPubMed
4.
Spoelstra SL, Given CW. Assessment and Measurement of Adherence to Oral Antineoplastic Agents. Semin Oncol Nurs. 2011;27:116–32.CrossRefPubMed
5.
Spoelstra SL, Given BA, Given CW, Grant M, Sikorskii A, You M, et al. An Intervention to Improve Adherence and Management of Symptoms for Patients Prescribed Oral Chemotherapy Agents: An Exploratory Study. Cancer Nurs. 2013;36:18–28.CrossRefPubMed
6.
Verbrugghe M, Verhaeghe S, Lauwaert K, Beeckman D, Van Hecke A. Determinants and associated factors influencing medication adherence and persistence to oral anticancer drugs: A systematic review. Cancer Treat Rev. 2013;39:610–21.CrossRefPubMed
7.
Bassan F, Peter F, Houbre B, Brennstuhl M, Costantini M, Speyer E, et al. Adherence to oral antineoplastic agents by cancer patients: definition and literature review. Eur J Cancer Care (Engl). 2014;23:22–35.CrossRef
8.
McCue DA, Lohr LK, Pick AM. Improving Adherence to Oral Cancer Therapy in Clinical Practice. Pharmacother J Hum Pharmacol Drug Ther. 2014;34:481–94.CrossRef
9.
Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009;59:56–66.CrossRefPubMed
10.
Weingart SN, Flug J, Brouillard D, Morway L, Partridge A, Bartel S, et al. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ. 2007;334:407.CrossRefPubMedPubMedCentral
11.
12.
Wilcox B, Bruce SD. Patient navigation: a “win-win” for all involved. Oncol Nurs Forum. 2010;37:21–5.CrossRefPubMed
13.
14.
Wells KJ, Meade CD, Calcano E, Lee J-H, Rivers D, Roetzheim RG. Innovative approaches to reducing cancer health disparities: the Moffitt Cancer Center Patient Navigator Research Program. J. Cancer Educ. Off. J. Am. Assoc. J Cancer Educ. 2011;26:649–57.CrossRefPubMedPubMedCentral
15.
McMullen L. Oncology nurse navigators and the continuum of cancer care. Semin Oncol Nurs. 2013;29:105–17.CrossRefPubMed
16.
Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, et al. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010;304:163–71.CrossRefPubMedPubMedCentral
17.
McCann L, Maguire R, Miller M, Kearney N. Patients’ perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS) to monitor and manage chemotherapy related toxicity. Eur J Cancer Care (Engl). 2009;18:156–64.CrossRef
18.
Clifford S, Perez-Nieves M, Skalicky AM, Reaney M, Coyne KS. A systematic literature review of methodologies used to assess medication adherence in patients with diabetes. Curr Med Res Opin. 2014;30:1071–85.CrossRefPubMed
19.
20.
Kvedar J, Coye MJ, Everett W. Connected Health: A Review Of Technologies And Strategies To Improve Patient Care With Telemedicine And Telehealth. Health Aff (Millwood). 2014;33:194–9.CrossRef
21.
Jean-Pierre P, Hendren S, Fiscella K, Loader S, Rousseau S, Schwartzbauer B, et al. Understanding the processes of patient navigation to reduce disparities in cancer care: perspectives of trained navigators from the field. J. Cancer Educ. Off. J. Am. Assoc. J Cancer Educ. 2011;26:111–20.CrossRefPubMedPubMedCentral
22.
Hoverman JR, Klein I, Harrison DW, Hayes JE, Garey JS, Harrell R, et al. Opening the Black Box: The Impact of an Oncology Management Program Consisting of Level I Pathways and an Outbound Nurse Call System. J Oncol Pract. 2014;10:63–7.CrossRefPubMed
23.
Schneider SM, Adams DB, Gosselin T. A tailored nurse coaching intervention for oral chemotherapy adherence. J Adv Pract Oncol. 2014;5:163.PubMedPubMedCentral
24.
Khandelwal N, Duncan I, Ahmed T, Rubinstein E, Pegus C. Oral chemotherapy program improves adherence and reduces medication wastage and hospital admissions. J Natl Compr Cancer Netw JNCCN. 2012;10:618–25.PubMed
25.
Lairson DR, Huo J, Ball Ricks KA, Savas L, Fernández ME. The cost of implementing a 2-1-1 call center-based cancer control navigator program. Eval Program Plann. 2013;39:51–6.CrossRefPubMed
26.
Kimman ML, Dirksen CD, Voogd AC, Falger P, Gijsen BCM, Thuring M, et al. Economic evaluation of four follow-up strategies after curative treatment for breast cancer: Results of an RCT. Eur J Cancer. 2011;47:1175–85.CrossRefPubMed
27.
Hendren S, Fiscella K. Patient navigation improves the care experience for patients with newly diagnosed cancer. J Clin Oncol. 2014;32:3–4.CrossRefPubMed
28.
Girault A, Ferrua M, Lalloué B, Sicotte C, Fourcade A, Yatim F, et al. Internet-based technologies to improve cancer care coordination: Current use and attitudes among cancer patients. Eur J Cancer. 2015;51:551–7.CrossRefPubMed
29.
Lyman GH, Dale DC, Tomita D, Whittaker S, Crawford J. A retrospective evaluation of chemotherapy dose intensity and supportive care for early-stage breast cancer in a curative setting. Breast Cancer Res Treat. 2013;139:863–72.CrossRefPubMed
30.
Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH, ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006;100:255–62.CrossRefPubMed
31.
Miyake H, Miyazaki A, Harada K-I, Fujisawa M. Assessment of efficacy, safety and quality of life of 110 patients treated with sunitinib as first-line therapy for metastatic renal cell carcinoma: experience in real-world clinical practice in Japan. Med Oncol Northwood Lond Engl. 2014;31:978.CrossRef
32.
Shirotake S, Yasumizu Y, Ito K, Masunaga A, Ito Y, Miyazaki Y, et al. Impact of Second-Line Targeted Therapy Dose Intensity on Patients With Metastatic Renal Cell Carcinoma. Clin. Genitourin. Cancer. 2016;in press.
33.
Kyrios M, Nedeljkovic M, Moulding R, Klein B, Austin D, Meyer D, et al. Study protocol for a randomised controlled trial of internet-based cognitive-behavioural therapy for obsessive-compulsive disorder. BMC Psychiatry. 2014;14:209.CrossRefPubMedPubMedCentral
34.
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet Lond Engl. 2001;357:1191–4.CrossRef
35.
Ward E, Jemal A, Cokkinides V, Singh GK, Cardinez C, Ghafoor A, et al. Cancer disparities by race/ethnicity and socioeconomic status. CA Cancer J Clin. 2004;54:78–93.CrossRefPubMed
36.
Clegg LX, Reichman ME, Miller BA, Hankey BF, Singh GK, Lin YD, et al. Impact of socioeconomic status on cancer incidence and stage at diagnosis: selected findings from the surveillance, epidemiology, and end results: National Longitudinal Mortality Study. Cancer Causes Control. 2009;20:417–35.CrossRefPubMed
37.
Ovretveit J. Evaluating Improvement and Implementation for Health. Maidenhead: Open University Press; 2014.
38.
Olomu AB, Stommel M, Holmes-Rovner MM, Prieto AR, Corser WD, Gourineni V, et al. Is quality improvement sustainable? Findings of the American College of Cardiology’s Guidelines Applied in Practice. Int J Qual Health Care. 2014;26:215–22.CrossRefPubMed
39.
Lee CR, Nicholson PW, Souhami RL, Slevin ML, Hall MR, Deshmukh AA. Patient compliance with prolonged low-dose oral etoposide for small cell lung cancer. Br J Cancer. 1993;67:630–4.CrossRefPubMedPubMedCentral
40.
Atkins L, Fallowfield L. Intentional and non-intentional non-adherence to medication amongst breast cancer patients. Eur J Cancer Oxf Engl 1990. 2006;42:2271–6.
41.
Craven O, Hughes CA, Burton A, Saunders MP, Molassiotis A. Is a nurse-led telephone intervention a viable alternative to nurse-led home care and standard care for patients receiving oral capecitabine? Results from a large prospective audit in patients with colorectal cancer: Nurse-led telephone follow-up in oral chemotherapy. Eur J Cancer Care (Engl). 2013;22:413–9.CrossRef
42.
Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value Health. 2013;16:231–50.CrossRefPubMed
43.
44.
Busse R, World Health Organization, European Observatory on Health Systems and Policies. Tackling chronic disease in Europe strategies, interventions and challenges [Internet]. Copenhagen: World Health Organization on behalf of the European Observatory on Health Systems and Policies; 2010 [cited 2014 Sep 11]. Available from: http://​site.​ebrary.​com/​id/​10404036
45.
Portela MC, Pronovost PJ, Woodcock T, Carter P, Dixon-Woods M. How to study improvement interventions: a brief overview of possible study types. BMJ Qual Saf. 2015;24:325–36.CrossRefPubMedPubMedCentral
46.
Rahurkar S, Vest JR, Menachemi N. Despite The Spread Of Health Information Exchange, There Is Little Evidence Of Its Impact On Cost, Use And Quality Of Care. Health Aff (Millwood). 2015;34:477–83.CrossRef
47.
Wulff CN, Thygesen M, Søndergaard J, Vedsted P. Case management used to optimize cancer care pathways: A systematic review. BMC Health Serv Res. 2008;8:227.CrossRefPubMedPubMedCentral
48.
Nielsen K. Review Article: How can we make organizational interventions work? Employees and line managers as actively crafting interventions. Hum Relat. 2013;66:1029–50.CrossRef
49.
Nielsen K, Taris TW, Cox T. The future of organizational interventions: Addressing the challenges of today’s organizations. Work Stress. 2010;24:219–33.CrossRef
50.
Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003;12:47–52.CrossRefPubMedPubMedCentral
51.
Avery AK, Del Toro M, Caron A. Increases in HIV screening in primary care clinics through an electronic reminder: an interrupted time series. BMJ Qual Saf. 2014;23:250–6.CrossRefPubMed
52.
Benn J, Burnett S, Parand A, Pinto A, Vincent C. Factors predicting change in hospital safety climate and capability in a multi-site patient safety collaborative: a longitudinal survey study. BMJ Qual Saf. 2012;21:559–68.CrossRefPubMed
53.
Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. The BMJ. 2015;350:h1258.CrossRefPubMedPubMedCentral
54.
Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006;332:413–6.CrossRefPubMedPubMedCentral
55.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5:649–55.CrossRefPubMed
56.
Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74.CrossRefPubMed
57.
Waterhouse DM, Calzone KA, Mele C, Brenner DE. Adherence to oral tamoxifen: a comparison of patient self-report, pill counts, and microelectronic monitoring. J. Clin. Oncol. Off. J. Am. Soc. Clin. J Clin Oncol. 1993;11:1189–97.PubMed
58.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer Oxf Engl 1990. 2009;45:228–47.
59.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRefPubMed
60.
Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005;43:436–44.CrossRefPubMed
Metadata
Title
Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial
Authors
Chloé Gervès-Pinquié
Fatima Daumas-Yatim
Benoît Lalloué
Anne Girault
Marie Ferrua
Aude Fourcade
François Lemare
Mario Dipalma
Etienne Minvielle
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2017
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-017-2066-x

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