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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Study protocol

Randomised controlled trial protocol (GRIP study): examining the effect of involvement of a general practitioner and home care oncology nurse after a cancer diagnosis on patient reported outcomes and healthcare utilization

Authors: I. A. A. Perfors, C. W. Helsper, E. A. Noteboom, E. van der Wall, N. J. de Wit, A. M. May

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

Due to the ageing population and improving diagnostics and treatments, the number of cancer patients and cancer survivors is increasing. Policymakers, patients and professionals advocate a transfer of (part of) cancer care from the hospital environment to the primary care setting, as this could stimulate personalized and integrated care, increase cost-effectiveness and would better meet the patients’ needs and expectations. The effects of structured active follow-up from primary care after cancer diagnosis have not been studied yet. Therefore the GRIP study aims to assess the effects of structured follow-up after a cancer diagnosis, by a primary care team including a general practitioner (GP) and a home care oncology nurse (HON), on satisfaction and healthcare utilization of patients treated with curative intent.

Methods

We will conduct a multicentre, two-arm randomised controlled trial in The Netherlands. We plan to include 150 patients who will be treated with curative intent for either breast, lung, colorectal, gynaecologic cancer, or melanoma. Further inclusion criteria are: age 18 years and older, able to answer questionnaires in Dutch, GP agrees to participate and the possibility to include the patient before the start of treatment. All patients receive care as usual. The intervention arm will receive additional structured follow-up consisting of a GP consultation before onset of treatment to empower the patient for shared decision making with the specialist and a minimum of three contacts with the HON during and after treatment. Primary outcomes are: patient satisfaction with care at the level of specialist, GP and nurse and healthcare utilization. Secondary outcomes include: quality of life, employment status, patient empowerment, shared decision making, mental health and satisfaction with given information. Repeated questionnaires, filled in by the participants, will be assessed within the 1-year study period.

Discussion

This randomised controlled trial will evaluate the effects of structured follow-up after a cancer diagnosis by a primary care team including a GP and HON, for patients undergoing treatment with curative intent. Results from the present study may provide the evidence needed to optimally rearrange responsibilities in cancer care delivery and consequently improve cancer care and patient related outcomes.

Trial registration

Trial number: NTR5909.
Literature
1.
go back to reference Integraal Kankercentrum Nederland. Leeftijd en geslacht. 2016. 6-7-2016. Integraal Kankercentrum Nederland. Leeftijd en geslacht. 2016. 6-7-2016.
2.
go back to reference Rubin G, Berendsen A, Crawford SM, Dommett R, Earle C, Emery J, et al. The expanding role of primary care in cancer control. Lancet Oncol. 2015;16:1231–72.CrossRefPubMed Rubin G, Berendsen A, Crawford SM, Dommett R, Earle C, Emery J, et al. The expanding role of primary care in cancer control. Lancet Oncol. 2015;16:1231–72.CrossRefPubMed
3.
go back to reference World Health Organisation. World Cancer Report 2014. Lyon: International Agency for Research on Cancer; 2014. p. 66. World Health Organisation. World Cancer Report 2014. Lyon: International Agency for Research on Cancer; 2014. p. 66.
4.
go back to reference Signaleringscommissie Kanker van KWF Kankerbestrijding. Nazorg bij kanker: de rol van de eerste lijn. Amsterdam: KWF Kankerbestrijding; 2018. Signaleringscommissie Kanker van KWF Kankerbestrijding. Nazorg bij kanker: de rol van de eerste lijn. Amsterdam: KWF Kankerbestrijding; 2018.
5.
go back to reference Health Council of the Netherlands. Follow-up in oncology. Identify objectives, substantiate actions. The Hague: Health Council of the Netherlands; 2007. Publication no. 2007/10. Health Council of the Netherlands. Follow-up in oncology. Identify objectives, substantiate actions. The Hague: Health Council of the Netherlands; 2007. Publication no. 2007/10.
6.
go back to reference Nederlands Huisartsen Genootschap. NHG Standpunt Oncologische zorg in de huisartsenpraktijk. 2014. Nederlands Huisartsen Genootschap. NHG Standpunt Oncologische zorg in de huisartsenpraktijk. 2014.
7.
go back to reference Ogle KS, Swanson GM, Woods N, Azzouz F. Cancer and Comorbidity: redefining chronic diseases. Cancer. 2000;88(3):653–63.CrossRefPubMed Ogle KS, Swanson GM, Woods N, Azzouz F. Cancer and Comorbidity: redefining chronic diseases. Cancer. 2000;88(3):653–63.CrossRefPubMed
8.
go back to reference Kehl KL, Landrum MB, Arora NK, Ganz PA, van Ryn M, Mack JW, et al. Shared decision making in cancer care: the association of actual and preferred decision roles with patient-reported quality. JAMA Oncol. 2015;1:50–8.CrossRefPubMedPubMedCentral Kehl KL, Landrum MB, Arora NK, Ganz PA, van Ryn M, Mack JW, et al. Shared decision making in cancer care: the association of actual and preferred decision roles with patient-reported quality. JAMA Oncol. 2015;1:50–8.CrossRefPubMedPubMedCentral
9.
go back to reference Chawla N, Arora NK. Why do some patients prefer to leave decisions up to the doctor: lack of self-efficacy or a matter of trust? J Cancer Surviv. 2013;7:592–601.CrossRefPubMed Chawla N, Arora NK. Why do some patients prefer to leave decisions up to the doctor: lack of self-efficacy or a matter of trust? J Cancer Surviv. 2013;7:592–601.CrossRefPubMed
11.
go back to reference Nederlandse Federatie van Universitair Medische Centra. NFU, NVZ, NFK: Nieuwe netwerken optimaliseren kankerzorg. 2014. 6-7-2016. Nederlandse Federatie van Universitair Medische Centra. NFU, NVZ, NFK: Nieuwe netwerken optimaliseren kankerzorg. 2014. 6-7-2016.
12.
go back to reference Klabunde CN, Ambs A, Keating NL, He Y, Doucette WR, Tisnado D, et al. The role of primary care physicians in cancer care. J Gen Intern Med. 2009;24:1029–36.CrossRefPubMedPubMedCentral Klabunde CN, Ambs A, Keating NL, He Y, Doucette WR, Tisnado D, et al. The role of primary care physicians in cancer care. J Gen Intern Med. 2009;24:1029–36.CrossRefPubMedPubMedCentral
13.
go back to reference Johansson B, Berglund G, Glimelius B, Holmberg L, Sjödén PO. Intensified primary cancer care: a randomized study of home care nurse contacts. J Adv Nurs. 1999;30:1137–46.CrossRefPubMed Johansson B, Berglund G, Glimelius B, Holmberg L, Sjödén PO. Intensified primary cancer care: a randomized study of home care nurse contacts. J Adv Nurs. 1999;30:1137–46.CrossRefPubMed
14.
go back to reference Johansson B, Holmberg L, Berglund G, Brandberg Y, Hellbom M, Persson C, et al. Reduced utilisation of specialist care among elderly cancer patients: a randomised study of a primary healthcare intervention. Eur J Cancer. 2001;37:2161–8.CrossRefPubMed Johansson B, Holmberg L, Berglund G, Brandberg Y, Hellbom M, Persson C, et al. Reduced utilisation of specialist care among elderly cancer patients: a randomised study of a primary healthcare intervention. Eur J Cancer. 2001;37:2161–8.CrossRefPubMed
15.
go back to reference Kousgaard KR, Nielsen JD, Olesen F, Jensen AB. General practitioner assessment of structured oncological information accompanying newly referred cancer patients. Scand J Prim Health Care. 2003;21:110–4.CrossRefPubMed Kousgaard KR, Nielsen JD, Olesen F, Jensen AB. General practitioner assessment of structured oncological information accompanying newly referred cancer patients. Scand J Prim Health Care. 2003;21:110–4.CrossRefPubMed
16.
go back to reference Nielsen JD, Palshof T, Mainz J, Jensen AB, Olesen F. Randomised controlled trial of a shared care programme for newly referred cancer patients: bridging the gap between general practice and hospital. Qual Saf Health Care. 2003;12:263–72.CrossRefPubMedPubMedCentral Nielsen JD, Palshof T, Mainz J, Jensen AB, Olesen F. Randomised controlled trial of a shared care programme for newly referred cancer patients: bridging the gap between general practice and hospital. Qual Saf Health Care. 2003;12:263–72.CrossRefPubMedPubMedCentral
17.
go back to reference Wallner LP, Abrahamse P, Uppal JK, Friese CR, Hamilton AS, Ward KC, et al. Involvement of primary care physicians in the decision making and Care of Patients with Breast Cancer. J Clin Oncol. 2016;20:3969–75.CrossRef Wallner LP, Abrahamse P, Uppal JK, Friese CR, Hamilton AS, Ward KC, et al. Involvement of primary care physicians in the decision making and Care of Patients with Breast Cancer. J Clin Oncol. 2016;20:3969–75.CrossRef
18.
go back to reference Drury M, Yudkin P, Harcourt J, Fitzpatrick R, Jones L, Alcock C, et al. Patients with cancer holding their own records: a randomised controlled trial. Br J Gen Pract. 2000;50:105–10.PubMedPubMedCentral Drury M, Yudkin P, Harcourt J, Fitzpatrick R, Jones L, Alcock C, et al. Patients with cancer holding their own records: a randomised controlled trial. Br J Gen Pract. 2000;50:105–10.PubMedPubMedCentral
19.
go back to reference Shepherd HL, Barratt A, Treverna LJ, McGeechan K, Carey K, Epstein RM, et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: a cross-over trial. Patient Educ Couns. 2011;84(3):379–85.CrossRefPubMed Shepherd HL, Barratt A, Treverna LJ, McGeechan K, Carey K, Epstein RM, et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: a cross-over trial. Patient Educ Couns. 2011;84(3):379–85.CrossRefPubMed
20.
go back to reference Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE. Screening and referral for psychosocial distress in oncologic practice. Cancer. 2008;113(4):870–8.CrossRefPubMed Tuinman MA, Gazendam-Donofrio SM, Hoekstra-Weebers JE. Screening and referral for psychosocial distress in oncologic practice. Cancer. 2008;113(4):870–8.CrossRefPubMed
21.
go back to reference Brédart A, Bottomley A, Blazeby M, Conroy T, Coens C, D'Haese S, et al. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005;41(14):2120–31.CrossRefPubMed Brédart A, Bottomley A, Blazeby M, Conroy T, Coens C, D'Haese S, et al. An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32). Eur J Cancer. 2005;41(14):2120–31.CrossRefPubMed
22.
go back to reference Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Medical Cost Questionnaire (iMCQ). Rotterdam: Institute for Medical Technology Assessment, Erasmus University Rotterdam; 2013. Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Medical Cost Questionnaire (iMCQ). Rotterdam: Institute for Medical Technology Assessment, Erasmus University Rotterdam; 2013.
23.
go back to reference Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of cancer QLQ-30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.CrossRefPubMed Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of cancer QLQ-30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.CrossRefPubMed
24.
go back to reference Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Productivity Cost Questionnaire (iPCQ). Rotterdam: Institute for Medical Technology Assessment, Erasmus University Rotterdam; 2013. Bouwmans C, Hakkaart-van Roijen L, Koopmanschap M, Krol M, Severens H, Brouwer W. Handleiding iMTA Productivity Cost Questionnaire (iPCQ). Rotterdam: Institute for Medical Technology Assessment, Erasmus University Rotterdam; 2013.
25.
go back to reference Schwarzer R, Jerusalem M. Generalized self-efficacy scale. In measures in health psychology: a user's portfolio. In: Johnston M, Weinman J, Windsor WS, editors. Casual and control beliefs. UK: NFER-NELSON; 1995. p. 35–7. Schwarzer R, Jerusalem M. Generalized self-efficacy scale. In measures in health psychology: a user's portfolio. In: Johnston M, Weinman J, Windsor WS, editors. Casual and control beliefs. UK: NFER-NELSON; 1995. p. 35–7.
27.
go back to reference Simon D, Schorr G, Wirtz M, Vodermaier A, Caspari C, Neuner B, et al. Development and first validation of the shared decision-making questionnaire (SDM-Q). Patient Educ Couns. 2006;63(3):319–27.CrossRefPubMed Simon D, Schorr G, Wirtz M, Vodermaier A, Caspari C, Neuner B, et al. Development and first validation of the shared decision-making questionnaire (SDM-Q). Patient Educ Couns. 2006;63(3):319–27.CrossRefPubMed
28.
go back to reference Maly RC, Frank JC, Marshall GN, Dimatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998;46(7):889–94.CrossRefPubMed Maly RC, Frank JC, Marshall GN, Dimatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998;46(7):889–94.CrossRefPubMed
29.
go back to reference Rumpf HJ, Meyer C, Hapke U, John U. Screening for mental health: validity of the MHI-5 using DSM-IV Axis I psychiatric disorders as gold standard. Psychiatry Res. 2001;105(3):243–53.CrossRefPubMed Rumpf HJ, Meyer C, Hapke U, John U. Screening for mental health: validity of the MHI-5 using DSM-IV Axis I psychiatric disorders as gold standard. Psychiatry Res. 2001;105(3):243–53.CrossRefPubMed
30.
go back to reference Arraras JI, Kuljanic-Vlasic K, Bjordal K, Yun YH, Efficace F, Holzner B, et al. EORTC QLQ-INFO26: a questionnaire to assess information given to cancer patients a preliminary analysis in eight countries. Psychooncology. 2007;16(3):249–54.CrossRefPubMed Arraras JI, Kuljanic-Vlasic K, Bjordal K, Yun YH, Efficace F, Holzner B, et al. EORTC QLQ-INFO26: a questionnaire to assess information given to cancer patients a preliminary analysis in eight countries. Psychooncology. 2007;16(3):249–54.CrossRefPubMed
31.
go back to reference Twisk JWR. Applied longitudinal data analysis for epidemiology: a practical guide. Cambridge: Cambridge University Press; 2003. Twisk JWR. Applied longitudinal data analysis for epidemiology: a practical guide. Cambridge: Cambridge University Press; 2003.
32.
go back to reference Denollet J. DS14: Standard Assessment of Negative Affectivity, Social Inhibition, and Type D Personality. Psychosom Med. 2005;67(1):89–97. Denollet J. DS14: Standard Assessment of Negative Affectivity, Social Inhibition, and Type D Personality. Psychosom Med. 2005;67(1):89–97.
Metadata
Title
Randomised controlled trial protocol (GRIP study): examining the effect of involvement of a general practitioner and home care oncology nurse after a cancer diagnosis on patient reported outcomes and healthcare utilization
Authors
I. A. A. Perfors
C. W. Helsper
E. A. Noteboom
E. van der Wall
N. J. de Wit
A. M. May
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4005-6

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