Titre Testing the feAsibility and efficacy on Patient - HEdS-FR

Recherche appliquée et développement
Angewandte Forschung und Entwicklung
Titre
Testing the feAsibility and efficacy on Patient outcomes of two differeNt
intensities of a lung cancer nurse intervention during early treatment: a
noncomparative, randomized phase II trial (APN lung cancer trial)
Acronyme
APN lung cancer trial
Statut (dates début-fin)
En cours
Requérant-e principal-e • Andrea Serena (Haute école de Santé Fribourg, http://www.heds-fr.ch/
(site)
Co-requérant-e (site)
• Manuela Eicher (Haute école de santé Fribourg, http://www.heds-fr.ch/)
• Prof. Dr. med. Serge Leyvraz: Centre Hospitalier Universitaire Vaudois
(CHUV), Lausanne
Collaborateur-trice(s)
• -Source de financement • Ra&D du domaine Santé de la HES-SO pour la préparation du projet
(partenaire financier)
(montant forfaitaire 2013) : http://www.hes-so.ch/fr
Résumé
The aim of this study is to test feasibility and efficacy of two different intensities
of Lung Cancer Nurse (LCN) interventions to decrease severity of patient
reported symptoms, unmet supportive care needs and to enhance self-care
self-efficacy. A non-comparative two-stage randomized phase II trial will be
conducted. Sixty-six lung cancer patients under chemotherapytreatment (with
or without radiotherapy) at Thoracic Cancer Center of CHUV will be randomized
in arm A and B and will be run as two parallel Simon’s optimal two-stage
designs. Patients within arm A will receive intervention of intensity level 1.
Patients within arm B will receive intervention of intensity level 2.
The intervention of intensity level 1 consists of two standardized face-to-face
(F2F) consultations provided by a trained and specialized LCN at the beginning
of the first, as well as during the second cycle of chemotherapy.
The intervention of intensity level 2, consists of the above described F2F
consultation and additional telephone consultations during the first and the
third cycle of chemotherapy. The aim of the consultation (intensity level 1 and
2) is to screen and support self- and symptom-management, to offer or refer to
psychosocial support and to initiate coordination of care within the
multidisciplinary team.
Randomization and data collection will be provided by a research collaborator
(RC). Study time points are defined as follows: T0 (start of 1st therapy cycle) to
set baseline; T1 (Day 8 of 2nd Cycle) and T2 (1st radiology control at the end of
chemotherapy treatment). At each time point participants will complete a
validated electronic questionnaire (Supportive Care Needs Screening Tool 9 and
Strategies, Used by Patients to Promote Health) of the Lung Cancer Symptom
Scale (LCSS). After approval from the canton’s ethics committee, data will be
gathered in University Hospital Lausanne’s Thoracic Cancer Center.
Severity of shortness of breath will be considered as primary outcome. Severity
of other lung cancer related symptoms, unmet supportive care needs and selfcare self-efficacy are included as secondary outcomes. Feasibility in terms of
acceptance will be analyzed by means of semi-structured interviews with 10
health care professionals on their overall experience as well as perceived
barriers and facilitators to collaborate with the LCN after quantitative data
collection has been completed. The intervention (intensity level 1 and 2) will be
deemed promising if 35% of patients improve by at least 10mm on the VAS
scale concerning shortness of breath (primary outcome) of the LCCS between
T1 and T2.An interim analysis will be performed after accrual of 19 patients per
Route des Cliniques 15, 1700 Fribourg / Freiburg
t. +41 (0)26 429 6000, f. +41 (0)26 429 6010, [email protected], www.heds-fr.ch
arm. Should in either arm at least 6 patients improve by at least 10mm on the
VAS scale of shortness of breath (primary outcome), the superior arm will be
continued while the inferior arm will be stopped. For each secondary outcome,
descriptive statistics will be provided for each arm at each time point.
Qualitative data analysis will be based on thematic analysis. Semi-structured
interviews will be tape-recorded, transcribed and independently coded by two
investigators.
Partenaire(s) de terrain
• Centre Hospitalier Universitaire Vaudois (CHUV)
• Institut Universitaire de Formation et de Recherche en Soins (IUFRS),
Université de Lausanne
Contact
• [email protected]
• +41 26 429 60 53
Valorisation (publications, • Gertsch, K. (2012). HAUTES ECOLES. Les diplômes qui assurent un job:
conférences, congrès)
Andrea Serena, 29 ans, infirmier clinicien spécialisé au CHUV, lausanne :
Apporter sa contribution dans le développement des soins, L’Hebdo en
ligne
le
20.06.2012
:
http://www.hebdo.ch/les_diplomes_qui_assurent_un_job_162050_.html,
magazine no 25 du 21 juin 2012.
• Sechet, V., Eicher, M., Griesser M., & Serena, A. (2013). Les besoins de
soins de support insatisfaits des patientes atteintes d’un cancer du sein
comparés à ceux des patients atteints d’un cancer du poumon : analyse
descriptive. 1ères journées francophones de la recherche en soins, 11-12
juin, Angers, France.
• Serena, A. (2014). Cancer du poumon, tabagisme et stigmatisation des
patients : quels enjeux pour les soins? Conférence donnée dans le cadre de
la journée de la Commission scientifique du domaine Santé HES-SO
"L'intolérable et le tolérable dans les soins: perspectives socio-historiques,
cliniques, éthiques et juridiques", 23 mai, Haute école de santé Vaud
(HESAV), Lausanne.
• Serena, A. (2014). L’intervention de l’infirmière référente pour le cancer du
poumon pendant le traitement initial : étude de faisabilité. Conférence
donnée dans le cadre du Café recherche : rencontres scientifiques de
l’Unité de Recherche en Santé, 13 mai, Haute école de santé Vaud
(HESAV), Lausanne.
• Serena, A. (2013). Beyound lung cancer: living with lung cancer during and
after treatment. Hämatologie & Onkologie, 5/13, 38-40.
• Serena, A. (2011). L’insatisfaction des besoins en soins de support chez les
patients atteints d’un cancer du poumon en fonction du genre, de l’âge et
du tabagisme : étude descriptive corrélationelle transversale. Master ès
Sciences en sciences infirmières, Université de Lausanne (Faculté de
biologie et de médecine, Ecole de médecine) et Haute école spécialisée de
Suisse occidentale (HES-SO, Domaine santé), Lausanne. Retrieved from
http://www.unil.ch/sciences-infirmieres/page90095.html
• Serena, A. (2012). Comment les infirmières peuvent-elles améliorer
l’autogestion des symptômes chez les patient-e-s atteint-e-s d’un cancer
du poumon avancé pendant la phase de radiothérapie. Soins en oncologie
/ Onkologiepflege, 3, 32.
• Serena, A. (2012). Les besoins en soins de support chez les patients
atteints d’un cancer du poumon: promotion de l’autogestion et
recommandations cliniques. congrès des soins en oncologie, 29 mars,
Bern.
02/07/2014 - Copyright©/HEdS-FR
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Serena, A. (2012). Verbessertes Selbstmanagement von Patienten mit
Lungenkrebs und Radiotherapie. Soins en oncologie / Onkologiepflege 3,
33.
Serena, A., & Eicher , M. (2013). Beyond Lung Cancer. 17th ECCO - 38th
ESMO - 32nd ESTRO European Cancer Congress (ECC2013), Amsterdam,
27th September - 1st October.
Serena, A., Griesser, A.-C., Sechet, V., & Eicher, M. (2013). Unmet
supportive care needs in lung and breast cancer: differences by tumour site
and by clinical pathways. 17th ECCO - 38th ESMO - 32nd ESTRO European
Cancer Congress (ECC2013), Amsterdam, 27th September - 1st October.
Poster
Serena, A., Griesser, A.-C., Leyvraz, S., Fucina, N., Peters, S., White, K., &
Eicher, M. (2013). Testing the feasibility of a lung Cancer nurse
coordination model during early treatment: phase II study (clinical trial in
progress). 15th World Conference on Lung Cancer, October 27 - October
31, Sydney, Australia.
Serena, A., Griesser, A.-C., Débarge, P., Fucina, N., & Eicher, M. (2012). Les
besoins en soins de support chez les patients atteints d’un cancer du
poumon. Soins en oncologie / Onkologiepflege, 3, 14-19.
Serena, A., Griesser, A.-C., Débarge, P., Fucina, N., Peters, S., & Eicher, M.
(2012). Unmet supportive care needs of lung cancer patients during the
chemotherapy phase : A descriptive study. Bulletin du Cancer Suisse /
Schweizer Krebsbulletin, 2, 116-120.
Serena, A., Griesser, A.-C., Débarge, P., Fucina, N., Peters, S., & Eicher, M.
(2012). Unmet Supportive Care Needs of Lung Cancer Patients During the
Chemotherapy Phase: A Descriptive Study. Bulletin luxembourgeois des
questions sociales, 29, 95-107.
Serena, A., Griesser, A.-C., & Eicher, M. (2012). L'insatisfaction des besoins
en soins de support chez les patients atteints d'un cancer du poumon. Des
pratiques
cliniques
novatrices,
optimiser
les
compétences
professionnelles. 5ème Congrès mondial du SIDIIEF, 20-24 mai, Genève.
Serena, A., Griesser, A.-C., & Eicher, M. (2012). Using the theory of selfcare deficit to identify unmet supportive care needs of lung cancer patients
during the chemotherapy phase: descriptive design. World Congress on
future nursing systems : New approaches - new evidence for 2020. 12th
IOS World Congress, May 10-13, Luxembourg.
Serena, A., Griesser, A. C., & Eicher, M. (2012). Unmet Supportive Care
Needs of Lung Cancer Patients During the Chemotherapy Phase Descriptive Design (Interim Results). European journal of oncology nursing,
vol. 16, S34-S35. The 8th European Oncology Nursing Society (EONS)
Spring Convention, 26-27 avril, Geneva.
Serena, A., Griesser, A.-C., Jeanmonod, J., Fucina, N., Leyvraz, S., Peters, S.,
White, K., & Eicher, M. (2014). Developing a Lung Cancer Nurse role using
the PEPPA framework: Role definition, strategic development and
implementation. Poster presented at MASCC/ISOO International
Symposium - Supportive Care in Cancer, June 26-28, Miami (Floride).
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