Lung Cancer Nurse Model: a Phase II Study

NCT ID: NCT02362204

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

University of Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Dr Manuela Eicher

Dean of research School of Health Sciences Fribourg-HEdS-FR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manuela Eicher, Dr

Role: STUDY_DIRECTOR

University of Freiburg

Locations

University Hospital of Lausanne

Lausanne, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Andrea Serena, MScN

Role: CONTACT

andrea.serena@hefr.ch

0041 21 314 76 74

Manuela Eicher, Dr.

Role: CONTACT

manuela.eicher@hefr.ch

0041 26 429 60 55

Facility Contacts

Andrea Serena, MScN

Role: primary

andrea.serena@chuv.ch

0041 21 314 76 74

Other Identifiers

UniversityFreiburg

Identifier Type: -

Identifier Source: org_study_id