Improved treatment adherence in socially vulnerable lung cancer patients. A clinical randomized intervention project
Ansvarlig/responsible:
Erik Jakobsen, overlæge, klinisk lektor, MPM, Hjerte, Lunge- og Karkirurgisk afdeling T, Odense Universitetshospital
Status oktober 2024
Aim
We have developed the NAVIGATE intervention to improve survival among vulnerable lung cancer patients through 1) nursing navigation, 2) monitoring of patient-reported symptoms and 3) physical exercise. The effect of the intervention is now being tested in a multicenter randomized study with the aim of including 518 vulnerable lung cancer patients.
Development of the NAVIAGTE intervention and pilot study
Study development took place during March 2020 – September 2021 and included the involvement of lung cancer patients and clinical experts in three phases when designing the intervention components and manual as well as the vulnerability screening instrument. The study protocol was published in BMJ Open in fall 2022. We conducted a pilot intervention-arm only study in Roskilde from October 2021-January 2022. A total of 30 patients were screened for vulnerability, 56% were vulnerable and 82% were included. Adjustments were made e.g. by including a higher flexibility regarding replacing in-person meetings and physical training at the hospital with telephone meetings and home-based training. The development process and the results of the pilot study were published in Science Reports Nature in December 2023.
Randomized controlled trial testing the effect of NAVIGATE
The multicenter RCT started in March 2022, and we have now screened 947 patients for vulnerability, 41% (N=392) were vulnerable and 37% (N=144) have been included. Recruitment will take place over the next 2,5 years (until December 2025) from Zealand University Hospital, Odense University Hospital, Vejle Hospital, Sønderborg Hospital, Gødstrup Hospital and Aalborg University Hospital. Gødstrup Hospital and Aalborg University Hospital were added as additional sites in October 2023 and July 2024, respectively.
Qualitative study: How do we meet the vulnerable cancer patient?
From the ongoing RCT and previous studies, we know that translating interventions into clinical practice is a major challenge, but no previous studies have examined how interventions targeted at vulnerable cancer patients are performed in clinical practice. In addition, no previous studies have examined patient and healthcare professionals’ perspectives on participation in such interventions. Field observations and interviews with nurse navigators and patients are almost finalized including a total of 14 days of observations have been completed at 5 hospitals and 14 interviews with patients have been conducted. The data collection on the nurses’ learning and implementation of the project’s manual and communication techniques from ‘Motivational Interviewing’ has been extended as Aalborg University Hospital recently was included in the RCT study. All 8 participating nurses have been interviewed and follow-up interviews are being conducted.
Study group
Professor, Susanne Dalton, senior researcher, Pernille Bidstrup and MD, Erik Jacobsen are principal investigators. The daily project coordinator for the RCT is postdoc Rikke Langballe. Postdoc Rikke Torenholt is coordinating the qualitative study. A multicenter consortium consisting of at least one nurse, physiotherapist and physician from each participating study center are conducting the intervention. Other close national collaboration partners include professor and head of the Danish National Center for Lung Cancer Research, Ole Hilberg, professor, physiotherapist Søren Thorgaard Skou and physiotherapist, PhD student Lars Bo Jørgensen. International collaboration partners include Dr. Karen Freund and Amy Michelle LeClair, Tufts University School of Medicine, and Professor Brendan McCormack, head of the Division of Nursing at Queen Margaret University in Edinburgh and professor in nursing at Zealand University Hospital.
Funding
The study is funded by the Danish Cancer Society ‘Knæk Cancer’ (grant no. R223-A13094-18-S68 and R344-A19635), The Novo Nordisk Foundation (grant no. NNF20OC0064570), The Independent Research Fond (grant no. 1030-00414B), Danish Research Center for Lung Cancer, Region Southern Denmark and Region Zealand Research Fond and the Danish Comprehensive Cancer Center. We have further received funding from Knæk Cancer in 2022 (grant no R344-A19635) to conduct the qualitative study exploring the patients’ and nurses’ perspectives on participating in the Navigate trial.
Student projects
A total of four master-level students and two bachelor students have examined issues related to the NAVIGATE study:
• Udforskning af sundhedskompetence, social støtte og helbredsrelateret livskvalitet blandt sårbare patienter med nydiagnosticeret lungekræft: Et tværsnitsstudie (0ne master student).
• Is exercise capacity at time of diagnosis associated with HRQoL and disease-specific symptoms among clinically and patient-reported vulnerable NSCLC patients? (one master student).
• Beyond Just Training. A Qualitative Study of Physiotherapists’ Professional Self-Understanding working with Vulnerable Lung Cancer Patients in Project Navigate (two master students).
• Interventioner der støtter kræftpatienter med lav socioøkonomisk status i at deltage og gennemføre behandling – et scoping review (two bachelor students).
Publications
• Langballe R, Dalton SO, Jakobsen E, Karlsen RV, Iachina M, Freund KM, Leclair A, Nielsen AS, Andersen EW, Rosthøj S, Jørgensen LB, Skou ST, Bidstrup PE. NAVIGATE – Improving survival in vulnerable lung cancer patients through nurse navigation, symptom monitoring and exercise: study protocol for a multicenter randomized controlled trial. BMJ Open, 2022 Oct 31; 12(10)
• Langballe R, Jakobsen E, Iachina M, Karlsen RV, Ehlers, JH, Svendsen MN, Bodtger U, Hilberg, O, Dalton SO, Bidstrup PE. Who are the vulnerable lung cancer patients at risk for not receiving first-line curative or palliative treatment? Acta Oncologica, 2023 Sep 1:1-8
• Langballe R, Svendsen, L., Jakobsen, E., Dalton, S. O., Karlsen, R. V., Iachina, M., Freund, K. M., Leclair, A., Jørgensen, L. B., Skou, S. T., Ehlers, J. H., Torenholt, R., Svendsen, M. N. & Envold Bidstrup, P. Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention. Sci Rep. 2023;13(1):22744.
Publications in preparation
• ‘Association between functional exercise capacity, physical activity, and Health-Related Quality of Life among vulnerable lung cancer patients at diagnosis: A cross-sectional study’
This study examines the association between Functional Exercise Capacity (FEC), weekly physical activity, and HRQoL among screened vulnerable lung cancer patients participating in the Navigate study.
• ‘Nurse navigation targeted vulnerable lung cancer patients: A qualitative study of nurses’ and patients’ interactional dynamics’
This study aims to examine how nurse navigation is accomplished through or confounded by the interactional work of nurses and patients in clinical encounters and how patients’ and healthcare professionals’ cultural resources, dispositions and interactional styles influence the clinical set-up around nurse navigation. The study draws on observations and audio recordings of 45 encounters between 15 patients and 8 nurse navigators and on 31 individual interviews with the 15 patients and 8 nurses.