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 2022

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 to include 518 vulnerable lung cancer patients.

Study development and pilot study
Study development took place during March 2020 – September 2021 and included 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. We conducted a pilot intervention-arm only study in Roskilde during 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 of 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 are expected to be published in 2023.

Randomized controlled trial
The multicenter RCT started in March 2022, and during the first six months of inclusion, we have screened 179 patients for vulnerability, 43% (N=77) were vulnerable and 36% (N=28) have been included. Recruitment will take place over the next 1.5 years from Sjællands Universitetshospital, Odense Universitetshospital, Vejle Sygehus and Sønderborg Sygehus. Gødstrup sygehus will be added as an additional site from October 2022.

Study group
Professor, Susanne Dalton, senior researcher, Pernille Bidstrup and MD, Erik Jacobsen are principle 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), 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.

Publications in review
• 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. In review BMJ Open.

• 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? Submitted for publication in European Journal of Cancer.

Publications in preparation.
• 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 health care professionals’ perspectives on participation in such interventions. We have thus applied for further funding to conduct a qualitative study exploring the patients’ and nurses perspectives on participating in the Navigate trial.