TY - JOUR

T1 - NAVIGATE

T2 - improving survival in vulnerable patients with lung cancer through nurse navigation, symptom monitoring and exercise - study protocol for a multicentre randomised controlled trial

AU - Langballe, Rikke

AU - Dalton, Susanne Oksbjerg

AU - Jakobsen, Erik

AU - Karlsen, Randi Valbjørn

AU - Iachina, Maria

AU - Freund, Karen M.

AU - Leclair, Amy

AU - Nielsen, Anette Søgaard

AU - Andersen, Elisabeth Anne Wreford

AU - Rosthøj, Susanne

AU - Jørgensen, Lars Bo

AU - Skou, Søren Thorgaard

AU - Bidstrup, Pernille Envold

N1 - Funding Information: This work is conducted as part of research activities in the Danish Research Center for Equality in Cancer, COMPAS and was supported 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.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - clinical trials

KW - oncology

KW - rehabilitation medicine

U2 - 10.1136/bmjopen-2021-060242

DO - 10.1136/bmjopen-2021-060242

M3 - Journal article

C2 - 36316074

AN - SCOPUS:85140943819

VL - 12

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

M1 - e060242

ER -