NCT04392908

Brief Summary

Present project aims to investigate memories related to a cancer communication diagnosis in pediatric oncology. It evaluates possible common elements and specificity between family and healthcare staff.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2019Dec 2026

Study Start

First participant enrolled

September 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

7.3 years

First QC Date

May 5, 2020

Last Update Submit

September 24, 2025

Conditions

Keywords

memorypediatric canceroncologycommunicationdiagnosis

Outcome Measures

Primary Outcomes (2)

  • Phenomenological characteristics of autobiographical memory

    Self report questionnaire "Assessment of the Phenomenology of Autobiographical Memory - APAM"

    One day after diagnosis

  • Emotional characteristics of autobiographical memory

    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

Study Arms (3)

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

Other: Communication memory

Parents

Parents of pediatric patients prior consent. Knowledge of fluent Italian language is required

Other: Communication memory

Medical Staff

Medical staff including doctor, psychologist and nurse

Other: Communication memory

Interventions

All groups will undergo audio-recorder interviews. Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.

Medical StaffParentsPatients

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with cancer diagnosis; their parents and healthcare staff

You may qualify if:

  • age from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
  • Italian speaking

You may not qualify if:

  • under 12 years old and above 17;
  • followed by other hospital;
  • cognitive disability
  • \- Italian speaking and signature informed consent.
  • \- cognitive disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meyer Children's Hospital

Florence, Firenze, 50139, Italy

Location

Related Publications (21)

  • Bury M. Chronic illness as biographical disruption. Sociol Health Illn. 1982 Jul;4(2):167-82. doi: 10.1111/1467-9566.ep11339939.

    PMID: 10260456BACKGROUND
  • Fioretti, C., & Smorti, A. (2015). How emotional content of memories changes in narrative. Narrative Inquire, 25(1), 37-56.

    BACKGROUND
  • 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.

    PMID: 27271542BACKGROUND
  • 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.

    PMID: 23640242BACKGROUND
  • 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.

    PMID: 10989622BACKGROUND
  • 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.

    BACKGROUND
  • Lancia, F. (2004). Strumenti per l'analisi dei testi: introduzione all'uso di T-Lab. Milano: Franco Angeli

    BACKGROUND
  • 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.

    PMID: 8664044BACKGROUND
  • 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.

    PMID: 10695815BACKGROUND
  • 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.

    PMID: 26613970BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 15518671BACKGROUND
  • Papini, M., Tringali, D., & Lauro-Grotto, R. (2011). La nostra era una vita normale. Ancona: Sorbello Editore.

    BACKGROUND
  • 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.

    PMID: 18623217BACKGROUND
  • Pennebaker, J., Fracis, M.E., & Booth, R.J. (2001). Linquistic Inquiry Word Count: LIWC 2001. Mahway: Lawrence Erlbaum Associates.

    BACKGROUND
  • Smorti, A. (2007). Narrazioni. Cultura, memorie, formazione del sé. Firenze: Giunti.

    BACKGROUND
  • Smorti, A. & Donzelli, G.P. (2015). La medicina narrativa in pediatria. Come le storie ci aiutano a capire la malattia. Firenze: SEID.

    BACKGROUND
  • 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.

    PMID: 15296044BACKGROUND
  • 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.

    PMID: 11234859BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32246729BACKGROUND

MeSH Terms

Conditions

NeoplasmsCommunicationDisease

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 19, 2020

Study Start

September 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations