NAVIGATE: improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial

Rikke Langballe, Susanne Oksbjerg Dalton, Erik Jakobsen, Randi Valbjørn Karlsen, Maria Iachina, Karen M Freund, Amy Leclair, Anette Søgaard Nielsen, Elisabeth Anne Wreford Andersen, Susanne Rosthøj, Lars Bo Jørgensen, Søren Thorgaard Skou, Pernille Envold Bidstrup, Rikke Langballe, Susanne Oksbjerg Dalton, Erik Jakobsen, Randi Valbjørn Karlsen, Maria Iachina, Karen M Freund, Amy Leclair, Anette Søgaard Nielsen, Elisabeth Anne Wreford Andersen, Susanne Rosthøj, Lars Bo Jørgensen, Søren Thorgaard Skou, Pernille Envold Bidstrup

Abstract

Introduction and aim: Low socioeconomic position (SEP) has been shown to be strongly associated with impaired lung cancer survival. Barriers related to receiving recommended treatment among patients with lung cancer with low SEP may include adverse health behaviour and limited physical and psychosocial resources influencing the ability to react on high-risk symptoms and to navigate the healthcare system. To address the underlying factors that drive both decisions of treatment, adherence to treatment and follow-up in vulnerable patients with lung cancer, we developed the Navigate intervention. The aim of this randomised controlled trial is to investigate the effect of the intervention on survival (primary outcome), lung cancer treatment adherence, health-related quality of life and other psychosocial outcomes as well as health costs and process evaluation (secondary outcomes) in a study population of vulnerable patients with lung cancer.

Methods and analysis: This two-armed multicentre randomised trial will recruit patients from five lung cancer clinics in Denmark identified as vulnerable according to a screening instrument with nine clinical and patient-reported vulnerability criteria developed for the study. We will enrol 518 vulnerable patients >18 years old diagnosed with non-small cell lung cancer at all stages with a performance status <2. Participants will be randomly allocated to either standard treatment and intervention or standard treatment alone. The Navigate intervention is based on principles from motivational interviewing and includes three components of nurse navigation, systematic monitoring of patient-reported outcomes (PROs) and physical exercise in a person-centred delivery model. Data will be collected at baseline and 3, 6, 12 months after randomisation using questionnaires, clinical data and physical function tests.

Ethics and dissemination: Ethics Committee, Region Zealand (SJ-884/EMN-2020-37380) and the Data Protection Agency in Region Zealand (REG-080-2021) approved the trial. Participants will provide written informed consent. Results will be reported in peer-reviewed journals.

Trial registration number: NCT05053997.

Keywords: clinical trials; oncology; rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow and intervention components. Source: iStockphoto.com/StefaNikolic/Rawpixel/SDI Productions.

References

    1. Bray F, Ferlay J, Soerjomataram I, et al. . Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394–424. 10.3322/caac.21492
    1. Mellemgaard A, Andersen JL, Seppo L. Medicinsk behandling AF lungecancer. Ugeskr Læger 2018;180:2088–91.
    1. Danish Lung Cancer Group (DLCG) . Annual report, 2021.
    1. Dalton SO, Steding-Jessen M, Engholm G, et al. . Social inequality and incidence of and survival from lung cancer in a population-based study in Denmark, 1994-2003. Eur J Cancer 2008;44:1989–95. 10.1016/j.ejca.2008.06.023
    1. Sidorchuk A, Agardh EE, Aremu O, et al. . Socioeconomic differences in lung cancer incidence: a systematic review and meta-analysis. Cancer Causes Control 2009;20:459–71. 10.1007/s10552-009-9300-8
    1. Forrest LF, Adams J, Wareham H, et al. . Socioeconomic inequalities in lung cancer treatment: systematic review and meta-analysis. PLoS Med 2013;10:e1001376. 10.1371/journal.pmed.1001376
    1. Kærgaard Starr L, Osler M, Steding-Jessen M, et al. . Socioeconomic position and surgery for early-stage non-small-cell lung cancer: a population-based study in Denmark. Lung Cancer 2013;79:262–9. 10.1016/j.lungcan.2012.11.023
    1. Dalton SO, Steding-Jessen M, Jakobsen E, et al. . Socioeconomic position and survival after lung cancer: influence of stage, treatment and comorbidity among Danish patients with lung cancer diagnosed in 2004-2010. Acta Oncol 2015;54:797–804. 10.3109/0284186X.2014.1001037
    1. Berglund A, Holmberg L, Tishelman C, et al. . Social inequalities in non-small cell lung cancer management and survival: a population-based study in central Sweden. Thorax 2010;65:327–33. 10.1136/thx.2009.125914
    1. Tendler S, Holmqvist M, Wagenius G, et al. . Educational level, management and outcomes in small-cell lung cancer (SCLC): a population-based cohort study. Lung Cancer 2020;139:111–7. 10.1016/j.lungcan.2019.11.008
    1. Willén L, Berglund A, Bergström S, et al. . Educational level and management and outcomes in non-small cell lung cancer. A nationwide population-based study. Lung Cancer 2019;131:40–6. 10.1016/j.lungcan.2019.03.004
    1. Ruiz-Pérez I, Rodríguez-Gómez M, Pastor-Moreno G, et al. . Effectiveness of interventions to improve cancer treatment and follow-up care in socially disadvantaged groups. Psychooncology 2019;28:665–74. 10.1002/pon.5011
    1. Sampedro Pilegaard M, Knold Rossau H, Lejsgaard E, et al. . Rehabilitation and palliative care for socioeconomically disadvantaged patients with advanced cancer: a scoping review. Acta Oncol 2021;60:112–23. 10.1080/0284186X.2020.1827156
    1. Freund KM, Battaglia TA, Calhoun E, et al. . Impact of patient navigation on timely cancer care: the patient navigation research program. J Natl Cancer Inst 2014;106:dju115. 10.1093/jnci/dju115
    1. Rodday AM, Parsons SK, Snyder F, et al. . Impact of patient navigation in eliminating economic disparities in cancer care. Cancer 2015;121:4025–34. 10.1002/cncr.29612
    1. Budde H, Williams GA, Winkelmann J, et al. . The role of patient navigators in ambulatory care: overview of systematic reviews. BMC Health Serv Res 2021;21:1166. 10.1186/s12913-021-07140-6
    1. Kotronoulas G, Kearney N, Maguire R, et al. . What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol 2014;32:1480–501. 10.1200/JCO.2013.53.5948
    1. Buffart LM, Kalter J, Sweegers MG, et al. . Effects and moderators of exercise on quality of life and physical function in patients with cancer: an individual patient data meta-analysis of 34 RCTs. Cancer Treat Rev 2017;52:91–104. 10.1016/j.ctrv.2016.11.010
    1. Mishra SI, Scherer RW, Snyder C, et al. . Exercise interventions on health-related quality of life for people with cancer during active treatment. Cochrane Database Syst Rev 2012:390–2. 10.1111/coa.12015
    1. Doerfler-Evans RE. Shifting paradigms continued-the emergence and the role of nurse navigator. J Thorac Dis 2016;8:S498–500. 10.21037/jtd.2016.04.03
    1. Zibrik K, Laskin J, Ho C. Integration of a nurse navigator into the triage process for patients with non-small-cell lung cancer: creating systematic improvements in patient care. Curr Oncol 2016;23:e280–3. 10.3747/co.23.2954
    1. Freund KM. Implementation of evidence-based patient navigation programs. Acta Oncol 2017;56:123–7. 10.1080/0284186X.2016.1266078
    1. Meade CD, Wells KJ, Arevalo M, et al. . Lay navigator model for impacting cancer health disparities. J Cancer Educ 2014;29:449–57. 10.1007/s13187-014-0640-z
    1. Mertz BG, Dunn-Henriksen AK, Kroman N, et al. . The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: a randomized pilot study. Acta Oncol 2017;56:1682–9. 10.1080/0284186X.2017.1358462
    1. Hunnibell LS, Rose MG, Connery DM, et al. . Using nurse navigation to improve timeliness of lung cancer care at a Veterans Hospital. Clin J Oncol Nurs 2012;16:29–36. 10.1188/12.CJON.29-36
    1. Zibrik K, Laskin J, Ho C. Implementation of a lung cancer nurse navigator enhances patient care and delivery of systemic therapy at the British Columbia cancer agency, Vancouver. J Oncol Pract 2016;12:e344–9. 10.1200/JOP.2015.008813
    1. Schofield P, Ugalde A, Gough K, et al. . A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial. Psychooncology 2013;22:2445–53. 10.1002/pon.3306
    1. Basch E, Deal AM, Kris MG, et al. . Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 2016;34:557–65. 10.1200/JCO.2015.63.0830
    1. Denis F, Lethrosne C, Pourel N, et al. . Randomized trial comparing a Web-Mediated follow-up with routine surveillance in lung cancer patients. J Natl Cancer Inst 2017;109:djx029. 10.1093/jnci/djx029
    1. Denis F, Basch E, Septans A-L, et al. . Two-Year survival comparing web-based symptom monitoring vs routine surveillance following treatment for lung cancer. JAMA 2019;321:306–7. 10.1001/jama.2018.18085
    1. Basch E, Deal AM, Dueck AC, et al. . Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 2017;318:197–8. 10.1001/jama.2017.7156
    1. Peddle-McIntyre CJ, Singh F, Thomas R, et al. . Exercise training for advanced lung cancer. Cochrane Database Syst Rev 2019;2:Cd012685. 10.1002/14651858.CD012685.pub2
    1. Quist M, Langer SW, Lillelund C, et al. . Effects of an exercise intervention for patients with advanced inoperable lung cancer undergoing chemotherapy: a randomized clinical trial. Lung Cancer 2020;145:76–82. 10.1016/j.lungcan.2020.05.003
    1. Kuehr L, Wiskemann J, Abel U, et al. . Exercise in patients with non-small cell lung cancer. Med Sci Sports Exerc 2014;46:656–63. 10.1249/MSS.0000000000000158
    1. Quist M, Rørth M, Langer S, et al. . Safety and feasibility of a combined exercise intervention for inoperable lung cancer patients undergoing chemotherapy: a pilot study. Lung Cancer 2012;75:203–8. 10.1016/j.lungcan.2011.07.006
    1. Irwin ML. Physical activity interventions for cancer survivors. Br J Sports Med 2009;43:32–8. 10.1136/bjsm.2008.053843
    1. Mazzoni A-S, Carlsson M, Berntsen S, et al. . "Finding my own motivation" - A Mixed Methods Study of Exercise and Behaviour Change Support During Oncological Treatment. Int J Behav Med 2019;26:499–511. 10.1007/s12529-019-09809-z
    1. Halgren MO, Kjær TK, Dalton SO. Hvidbog - Social ulighed i kræft i Danmark, 2019.
    1. Grimmett C, Bradbury K, Dalton SO, et al. . The role of behavioral science in personalized multimodal prehabilitation in cancer. Front Psychol 2021;12:634223. 10.3389/fpsyg.2021.634223
    1. Spencer JC, Wheeler SB. A systematic review of motivational interviewing interventions in cancer patients and survivors. Patient Educ Couns 2016;99:1099–105. 10.1016/j.pec.2016.02.003
    1. Mikkelsen MK, Lund CM, Vinther A, et al. . Engaging the older cancer patient; Patient Activation through Counseling, Exercise and Mobilization - Pancreatic, Biliary tract and Lung cancer (PACE-Mobil-PBL) - study protocol of a randomized controlled trial. BMC Cancer 2018;18:934. 10.1186/s12885-018-4835-2
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687. 10.1136/bmj.g1687
    1. Agemi Y, Shimokawa T, Sasaki J, et al. . Prospective evaluation of the G8 screening tool for prognostication of survival in elderly patients with lung cancer: a single-institution study. PLoS One 2019;14:e0210499. 10.1371/journal.pone.0210499
    1. Rowbottom L, Loucks A, Jin R, et al. . Performance of the vulnerable elders survey 13 screening tool in identifying cancer treatment modification after geriatric assessment in pre-treatment patients: a retrospective analysis. J Geriatr Oncol 2019;10:229–34. 10.1016/j.jgo.2018.10.018
    1. O'Cathain A, Croot L, Duncan E, et al. . Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open 2019;9:e029954. 10.1136/bmjopen-2019-029954
    1. World Health Organization . WHO guidelines on physical activity and sedentary behaviour. Geneva: WHO, 2020.
    1. Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc 1982;14:377–81.
    1. Antonio M, Saldaña J, Linares J, et al. . Geriatric assessment may help decision-making in elderly patients with inoperable, locally advanced non-small-cell lung cancer. Br J Cancer 2018;118:639–47. 10.1038/bjc.2017.455
    1. Nipp RD, Thompson LL, Temel B, et al. . Screening tool identifies older adults with cancer at risk for poor outcomes. J Natl Compr Canc Netw 2020;18:305–13. 10.6004/jnccn.2019.7355
    1. Tsubata Y, Shiratsuki Y, Okuno T, et al. . Prospective clinical trial evaluating vulnerability and chemotherapy risk using geriatric assessment tools in older patients with lung cancer. Geriatr Gerontol Int 2019;19:1108–11. 10.1111/ggi.13781
    1. Bergman B, Aaronson NK, Ahmedzai S, et al. . The EORTC QLQ-LC13: a modular supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 1994;30:635–42. 10.1016/0959-8049(94)90535-5
    1. Aaronson NK, Ahmedzai S, Bergman B, 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. 10.1093/jnci/85.5.365
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol group. Ann Med 2001;33:337–43. 10.3109/07853890109002087
    1. Troosters T, Gosselink R, Decramer M. Six minute walking distance in healthy elderly subjects. Eur Respir J 1999;14:270–4. 10.1034/j.1399-3003.1999.14b06.x
    1. Jones CJ, Rikli RE, Beam WC. A 30-S chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport 1999;70:113–9. 10.1080/02701367.1999.10608028
    1. Bohannon RW. Muscle strength: clinical and prognostic value of hand-grip dynamometry. Curr Opin Clin Nutr Metab Care 2015;18:465–70. 10.1097/MCO.0000000000000202
    1. Yorke AM, Curtis AB, Shoemaker M, et al. . Grip strength values stratified by age, gender, and chronic disease status in adults aged 50 years and older. J Geriatr Phys Ther 2015;38:115–21. 10.1519/JPT.0000000000000037
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Petersson F, Baadsgaard M, Thygesen LC. Danish registers on personal labour market affiliation. Scand J Public Health 2011;39:95–8. 10.1177/1403494811408483
    1. Moyers TB, Manuel JK, Ernst D. Motivational interviewing treatment integrity coding manual 4.1, 2014.
    1. Li Q, Su L. Accommodating informative dropout and death: a joint modelling approach for longitudinal and semi-competing risks data. J R Stat Soc Ser C Appl Stat 2018;67:145–63. 10.1111/rssc.12210
    1. Kurland BF, Johnson LL, Egleston BL, et al. . Longitudinal data with follow-up truncated by death: match the analysis method to research aims. Stat Sci 2009;24:211. 10.1214/09-STS293
    1. Hernán M, Robins J. Causal inference: what if. Boca Raton: Chapman & Hall/CRC, 2020.
    1. Nielsen AS, Kidholm K, Kayser L. Patients' reasons for non-use of digital patient-reported outcome concepts: a scoping review. Health Informatics J 2020;26:1460458220942649. 10.1177/1460458220942649
    1. Boutron I, Moher D, Altman DG, et al. . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295–309. 10.7326/0003-4819-148-4-200802190-00008

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