AP2 – Socially vulnerable patients

Improved treatment adherence in socially vulnerable lung cancer patients. A clinical randomized intervention project

Erik Jakobsen, overlæge, klinisk lektor, MPM, Hjerte, Lunge- og Karkirurgisk afdeling T, Odense Universitetshospital

Status oktober 2023

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.

Study development 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 have been submitted to Science Reports Nature in August 2023.

Randomized controlled trial
The multicenter RCT started in March 2022, and we have now screened 534 patients for vulnerability, 43% (N=232) were vulnerable and 39% (N=90) have been included. Recruitment will take place over the next 2,5 years (until December 2025) from Zealand University Hospital, Odense University Hospital, Vejle Sygehus and Sønderborg Sygehus. Gødstrup Hospital is expected to be added as an additional site from October 2023.

Study group
Professor, Susanne Dalton, senior researcher, Pernille Bidstrup and MD, Erik Jacobsen are principal investigators. The daily project coordinator is postdoc Rikke Langballe. 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.

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.

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 SO, Karlsen RV, Iachina M, et al. Addressing disparities in lung cancer survival: feasibility of the NAVIGATE intervention targeting vulnerable patients at risk of non-adherence to treatment Scientific Reports. Accepted for publication Dec 2023.

 Publications in review 
Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: Feasibility of the NAVIGATE intervention 
In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial.
Status: Manuscript submitted to Science Reports Nature in August 2023 

New projects initiated based on the NAVIGATE trial 
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 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. We have received further funding from Knæk Cancer in 2022 (grant no R344-A19635) to conduct a qualitative study exploring the patients’ and nurses' perspectives on participating in the Navigate trial. 
Status: We have appointed a postdoc Rikke Torenholt, who started in April 2023, and she is now conducting field observations and interviews with nurse navigators and patients.