Clinical trial NCT02362204: Lung Cancer Nurse Model: a Phase II Study
Official title: Development and Feasibility of a Lung Cancer Nurse Model During Early Treatment: a Phase II Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: University of Freiburg
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2015-02-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients newly diagnosed receiving systemic therapy

Brief summary: Lung cancer patients experience significant physical symptoms, psychological distress and have many supportive care needs that impact on quality of life. Implementing the role of a Lung Cancer Nurse (LCN) is a response to meet the needs of patients and caregivers.

Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect longitudinal patient self-assessment questionnaires at the Thoracic Cancer Centre of the University Hospital of Lausanne.

Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet supportive care needs across three time points during the first line therapy and ii) to explore professional acceptability of the new LCN model evaluating the perceptions of barriers and facilitators of the model by the LCN and the other multidisciplinary members of the comprehensive lung cancer care team.

An exact single-stage (no interim analysis) design will be applied to determine feasibility for further studies to be undertaken. Secondary outcomes will be analyzed descriptively at each data collection (Baseline, Time1, Time2) time point and professional acceptability will be explored by focus groups with selected members of the interdisciplinary team.

Detailed description: To develop adequate self-care strategies, patients with lung cancer and their families are in need of emotional, informational and behavioural supportive care. Supportive care in cancer can reduce symptom burden and improve patients and their families self-management skills. As lung cancer incidence continues to rise, and increased attention is given to early diagnosis, research on early involvement of lung cancer nurse (LCN) in care, the feasibility and impact on patient outcomes is needed.

Primary aim is to assess the feasibility of a LCN intervention and feasibility to collect longitudinal (Baseline, Time1, Time2) patient self-assessment questionnaires at the Thoracic Cancer Centre of the University Hospital of Lausanne.

Secondary aims are: i) to describe self-reported changes in self-efficacy, symptoms and unmet supportive care needs across three time points during the first line therapy and ii) to explore professional acceptability of the new LCN model evaluating the perceptions of barriers and facilitators of the model by the LCN and the other multidisciplinary members of the comprehensive lung cancer care team.

An exact single-stage (no interim analysis) design will be applied to determine feasibility for further studies to be undertaken. Lung cancer patients with planned systemic therapy with or without radiotherapy will be recruited at the thoracic cancer center in a Swiss University Hospital. The LCN model of care consists of two face-to-face consultations alternating with two telephone consultations during systemic therapy. LCN consultations will comprise focused assessment of physical and psychological symptoms, information (printed and oral) about disease and its treatment, therapeutic education concerning strategies to manage physical and psychosocial symptoms and review of available support resources. Participants will be invited to complete the validated patient reported Lung Cancer Symptom Scale, Supportive Care Needs Screening Tool 9 and Self-Efficacy Scale for Lung Cancer. Study data will be collected at baseline (day 1 of systemic therapy), time 1 (week 3 of systemic therapy) and time 2 (week 11 of systemic therapy). Participants will be categorized as adherent if they complete all their scheduled LCN consultations and questionnaires. For a 5% probability of accepting a poor feasibility (alpha) and a 20% probability of rejecting an acceptable feasibility (beta) we then need to enroll 71 patients. Feasibility will be considered as acceptable for further studies if at least 36 patients will be compliant. Secondary outcomes will be analyzed descriptively for each variable (self-efficacy, symptoms and supportive care needs) across each time point. At the end of quantitative data collection, a focus group will be conducted to explore acceptability of the new role among health professionals working with the LCN in order to identify perceived barriers and facilitators for collaborative work with the new role.

Eligibility criteria: Inclusion Criteria:

* Patients newly diagnosed lung cancer (NSCLC or SCLC)
* Patients capable of speaking and writing in French
* Patients undergoing programmed a systemic treatment (with or without radiotherapy treatment)
* Estimated life expectancy more than 6-months
* Signing the written informed consent document

Exclusion Criteria:

* Patients diagnosed with lung cancer receiving only surgery treatment or only a radiotherapy treatment
* Patients not physically or emotionally capable of participating in the trial as determined by their oncologist (existing mental illness or severe physical disability)

Primary outcomes:
measure: Feasibility
timeFrame: 11 weeks
Secondary outcomes:
measure: Lung cancer symptoms
timeFrame: Baseline-Week 3- Week 11
measure: Unmet Supportive Care Need
timeFrame: Baseline-Week 3- Week 11
measure: Self-efficacy
timeFrame: Baseline-Week 3- Week 11
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: University of Freiburg
name: Manuela Eicher, Dr
role: STUDY_DIRECTOR
References: