Lung Cancer Nurse Model: a Phase II Study

Lung Cancer Clinical Trial

— LCN-II  

Official title:

Development and Feasibility of a Lung Cancer Nurse Model During Early Treatment: a Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02362204
• Other study ID #: UniversityFreiburg
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2015
• Last updated: February 7, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: University of Freiburg
• Contact: Andrea Serena, MScN
• Phone: 0041 21 314 76 74
• Email: andrea.serena[@]hefr.ch
• Is FDA regulated: No
• Health authority: Human Research Ethics Committee, Canton Vaud: Switzerland
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• therapeutic education and psychological support
Intervention consists of alternate face-to-face consultations (anticipated duration: 60-90 minutes) and telephone consultations (anticipated duration: 15-30 minutes). All interventions will include: i) a focused assessment of physical and psychological symptoms, ii) information about lung cancer (disease) and its treatment, iii) a review of disease-related and treatment-related side effects and strategies to manage these symptoms, and iv) printed listing and review of available support resources.

Locations

Country	Name	City	State
Switzerland	University Hospital of Lausanne	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Freiburg	University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	For a 5% probability of accepting a poor feasibility and a 20% probability of rejecting an acceptable feasibility we need to enroll 71 patients. Feasibility will be considered as acceptable for further studies if at least 36 patients reach the end of the study completing their scheduled Lung Cancer Nurse consultations and patients completed the three questionnaire at each data collect time (baseline, time 1 and time 2)	11 weeks	No
Secondary	Lung cancer symptoms	Symptoms will be measured by the Lung Cancer Symptom Scale .This inventory consists of 9 items relating to appetite, fatigue, cough, dyspnea, hemoptysis, and pain related to lung malignancies and three summary items on symptom distress, interference with activity level, and global health-related quality of life. Each item is scored on a visual scale 0-100 (0=no symptom; 100 symptom as bad as can be).	Baseline-Week 3- Week 11	No
Secondary	Unmet Supportive Care Need	Unmet Supportive Care Needs will be measured by the the Supportive Care Needs Survey Screening Tool 9 (SCNS ST 9). The 9 items of the scale fall into five analytically derived factor domains: i) psychological, ii) health system and information, iii) physical and daily living, iv) patient care and support, and v) sexuality. Each item is rated on a 5-point Likert-type scale (not applicable=1; satisfied=2; low need=3; moderate need=4; High need=5).	Baseline-Week 3- Week 11	No
Secondary	Self-efficacy	Self-efficacy will be measured by the Self-Efficacy Scale for lung cancer. This scale is composed by 16 items regarding patients' perceived ability to manage a variety of symptoms on a scale of 10 (not at all certain) to 100 (completely certain). The instrument includes three subscale concerning: i) self-efficacy for managing pain, ii) self-efficacy for managing other symptoms, and iii) self-efficacy for functions.	Baseline-Week 3- Week 11	No