- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362204
Lung Cancer Nurse Model: a Phase II Study (LCN-II)
Development and Feasibility of a Lung Cancer Nurse Model During Early Treatment: a Phase II Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Andrea Serena, MScN
- Phone Number: 0041 21 314 76 74
- Email: andrea.serena@hefr.ch
Study Contact Backup
- Name: Manuela Eicher, Dr.
- Phone Number: 0041 26 429 60 55
- Email: manuela.eicher@hefr.ch
Study Locations
-
-
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Lausanne, Switzerland, 1004
- Recruiting
- University Hospital of Lausanne
-
Contact:
- Andrea Serena, MScN
- Phone Number: 0041 21 314 76 74
- Email: andrea.serena@chuv.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility
Time Frame: 11 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung cancer symptoms
Time Frame: Baseline-Week 3- Week 11
|
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
|
Unmet Supportive Care Need
Time Frame: Baseline-Week 3- Week 11
|
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).
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Baseline-Week 3- Week 11
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Self-efficacy
Time Frame: Baseline-Week 3- Week 11
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Manuela Eicher, Dr, University of Freiburg
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversityFreiburg
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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