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Lung CancerLCN-IINCT02362204

Lung Cancer Nurse Model: a Phase II Study

An observational study of Lung Cancer, run by University of Freiburg at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
therapeutic education and psychological support
How many people
71 participants
Where
1 siteSwitzerland
Study dates
Jan 2015to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Lung cancer patients newly diagnosed receiving systemic therapy

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Andrea Serena, MScN contact

0041 21 314 76 74

andrea.serena@hefr.ch

Manuela Eicher, Dr. contact

0041 26 429 60 55

manuela.eicher@hefr.ch

Switzerland1 site, 1 recruiting
  • University Hospital of Lausanne

    Lausanne, 1004

    Andrea Serena, MScN, 0041 21 314 76 74, andrea.serena@chuv.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Read the 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
Being tested
therapeutic education and psychological support
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • therapeutic education and psychological supportBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 11 weeks

Secondary outcomes (3)
  1. 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).

    Measured: Baseline-Week 3- Week 11

  2. 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).

    Measured: Baseline-Week 3- Week 11

  3. 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.

    Measured: Baseline-Week 3- Week 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionSep 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362204
Sponsor's protocol ID
UniversityFreiburg
Acronym
LCN-II
Status last verified
Feb 2015
First submitted
7 Feb 2015
Last updated
12 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by University of Freiburg at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea Serena, MScN (0041 21 314 76 74, andrea.serena@hefr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 11 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2015.

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Lung Cancer Nurse Model: a Phase II Study | AzTrials