- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392908
Communication Memory of Cancer Diagnosis Within the Pediatric Triangle
Communication Memory of Cancer Diagnosis Within Pediatric Triangle: a Cross-sectional Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lots of scientific evidences have shown that autobiographical episodes' narrative has a beneficial effect on the elaboration of memories. Indeed, narrating is a way to order thoughts and moods, which are connected to particular episodes of one's life, in order to rework and relive them. Since the diagnosis, a relationship and an open and sincere dialogue between the various parts of the pediatric triangle can promote a process of adaptation to the experience of illness and an integrated biopsychosocial healing. The first aim of this study is to explore and analyze autobiographical memories of pediatric patients, parents and healthcare staff. Also, it aims to investigate possible common and discordant element between deposition.
Phases of the present study:
- Sample recruitment and informed consent collection.
- Diagnosis communication audio recording.
- Communication of the autobiographical memory of the diagnosis audio recording of patients, parents, oncologist, nurse and psychologists involved, the day after the communication.
- Questionnaire APAM administration for adult participants.
- Audio Transcription and data coded. Data will be registered and operated by means of statistical software as SPSS (IBM) and T-Lab (Lancia, 2004).
- Statistical processing: ANOVA and t of Student tests will be implemented in order to compare collected questionnaires. Narrative analysis will be implemented by means of textual analysis software.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Firenze
-
Florence, Firenze, Italy, 50139
- Meyer Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria for pediatric patients:
- age from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
- Italian speaking
Exclusion criteria for pediatric patients:
- under 12 years old and above 17;
- followed by other hospital;
- cognitive disability
Inclusion criteria for parents:
- Italian speaking and signature informed consent.
Exclusion criteria for parents:
- cognitive disability
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Pediatric patients from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
Knowledge of fluent Italian language is required
|
All groups will undergo audio-recorder interviews.
Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
|
|
Parents
Parents of pediatric patients prior consent.
Knowledge of fluent Italian language is required
|
All groups will undergo audio-recorder interviews.
Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
|
|
Medical Staff
Medical staff including doctor, psychologist and nurse
|
All groups will undergo audio-recorder interviews.
Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phenomenological characteristics of autobiographical memory
Time Frame: One day after diagnosis
|
Self report questionnaire "Assessment of the Phenomenology of Autobiographical Memory - APAM"
|
One day after diagnosis
|
|
Emotional characteristics of autobiographical memory
Time Frame: One day after diagnosis
|
linguistic analysis by Linguistic Inquiry Word Count - LIWC; cluster analysis by T-Lab; Content analysis; coherence and narrative structure by High Point Anaysis.
|
One day after diagnosis
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Chiara Fioretti, PhD, Laboratorio di Metodi e Tecniche di Analisi delle Esperienze di Malattia Dipartimento di Scienze della Formazione e Psicologia, Università degli Studi di Firenze
Publications and helpful links
General Publications
- Bury M. Chronic illness as biographical disruption. Sociol Health Illn. 1982 Jul;4(2):167-82. doi: 10.1111/1467-9566.ep11339939.
- Fioretti, C., & Smorti, A. (2015). How emotional content of memories changes in narrative. Narrative Inquire, 25(1), 37-56.
- Fioretti C, Smorti A. Narrating positive versus negative memories of illness: does narrating influence the emotional tone of memories? Eur J Cancer Care (Engl). 2017 May;26(3). doi: 10.1111/ecc.12524. Epub 2016 Jun 8.
- Giffard B, Viard A, Dayan J, Morel N, Joly F, Eustache F. Autobiographical memory, self, and stress-related psychiatric disorders: which implications in cancer patients? Neuropsychol Rev. 2013 Jun;23(2):157-68. doi: 10.1007/s11065-013-9233-6. Epub 2013 May 3.
- Habermas T, Bluck S. Getting a life: the emergence of the life story in adolescence. Psychol Bull. 2000 Sep;126(5):748-69. doi: 10.1037/0033-2909.126.5.748.
- Jankovic, M. & Puricelli, E. (2008). La comunicazione della diagnosi al bambino. In S. M. G. Adamo (A cura di), La cura della relazione in oncologia pediatrica. Milano: Raffaello Cortina.
- Lancia, F. (2004). Strumenti per l'analisi dei testi: introduzione all'uso di T-Lab. Milano: Franco Angeli
- Last BF, van Veldhuizen AM. Information about diagnosis and prognosis related to anxiety and depression in children with cancer aged 8-16 years. Eur J Cancer. 1996 Feb;32A(2):290-4. doi: 10.1016/0959-8049(95)00576-5.
- Levi RB, Marsick R, Drotar D, Kodish ED. Diagnosis, disclosure, and informed consent: learning from parents of children with cancer. J Pediatr Hematol Oncol. 2000 Jan-Feb;22(1):3-12. doi: 10.1097/00043426-200001000-00002.
- Malterud K, Siersma VD, Guassora AD. Sample Size in Qualitative Interview Studies: Guided by Information Power. Qual Health Res. 2016 Nov;26(13):1753-1760. doi: 10.1177/1049732315617444. Epub 2016 Jul 10.
- McAdams, D. P. (2008). Personal narratives and the life story. In R. John, W. Robins & L. Pervin (Eds.), Handbook of personality: Theory and Research (3rd edn, pp. 241-261). New York: Guilford Press.
- Nilsson-Ihrfelt E, Fjallskog ML, Liss A, Jakobsson O, Blomqvist C, Andersson G. Autobiographical memories in patients treated for breast cancer. J Psychosom Res. 2004 Oct;57(4):363-6. doi: 10.1016/j.jpsychores.2004.01.009.
- Papini, M., Tringali, D., & Lauro-Grotto, R. (2011). La nostra era una vita normale. Ancona: Sorbello Editore.
- Parker TM, Johnston DL. Parental perceptions of being told their child has cancer. Pediatr Blood Cancer. 2008 Oct;51(4):531-4. doi: 10.1002/pbc.21667.
- Pennebaker, J., Fracis, M.E., & Booth, R.J. (2001). Linquistic Inquiry Word Count: LIWC 2001. Mahway: Lawrence Erlbaum Associates.
- Smorti, A. (2007). Narrazioni. Cultura, memorie, formazione del sé. Firenze: Giunti.
- Smorti, A. & Donzelli, G.P. (2015). La medicina narrativa in pediatria. Come le storie ci aiutano a capire la malattia. Firenze: SEID.
- Sobo EJ. Good communication in pediatric cancer care: a culturally-informed research agenda. J Pediatr Oncol Nurs. 2004 May-Jun;21(3):150-4. doi: 10.1177/1043454204264408.
- Tates K, Meeuwesen L. Doctor-parent-child communication. A (re)view of the literature. Soc Sci Med. 2001 Mar;52(6):839-51. doi: 10.1016/s0277-9536(00)00193-3.
- Vannucci, M., Marchetti, I., Manili, A., Chiorri, C. (2010). "Come" ricordiamo il passato: Un nuovo strumento sulla fenomenologia della memoria autobiografica. Congresso Nazionale AIP; Sezione di Psicologia Sperimentale, Bologna, 2-4 Settembre 2010.
- Vannucci M, Chiorri C, Marchetti I. Shaping our personal past: Assessing the phenomenology of autobiographical memory and its association with object and spatial imagery. Scand J Psychol. 2020 Oct;61(5):599-606. doi: 10.1111/sjop.12639. Epub 2020 Apr 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Communication in oncology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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