MemoryNCT04392908
Communication Memory of Cancer Diagnosis Within the Pediatric Triangle
An observational study of Memory, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Memory
- What is being tested?
- Communication memory
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with cancer diagnosis; their parents and healthcare staff
Who may be able to join
- age from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
- Italian speaking
- Italian speaking and signature informed consent.
Who cannot join
- under 12 years old and above 17;
- followed by other hospital;
- cognitive disability
- cognitive disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Communication Memory of Cancer Diagnosis Within Pediatric Triangle: a Cross-sectional Observational Study
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.
Read the 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.
- Conditions
- Memory
- Being tested
- Communication memory
- Keywords
- memory, pediatric cancer, oncology, communication, diagnosis
- Medical subject headings
- Neoplasms, Communication, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication memoryOther
All groups will undergo audio-recorder interviews. Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Communication memory | |
| Parents | Parents of pediatric patients prior consent. Knowledge of fluent Italian language is required Receives: Other: Communication memory | |
| Medical Staff | Medical staff including doctor, psychologist and nurse Receives: Other: Communication memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenomenological characteristics of autobiographical memory
Self report questionnaire "Assessment of the Phenomenology of Autobiographical Memory - APAM"
Measured: 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.
Measured: One day after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Sep 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for MemoryStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence
- Responsible party
- Principal investigator, Rosanna Martin, Meyer Children's Hospital IRCCS
- Investigators
- Chiara Fioretti, PhD, Study chair, Laboratorio di Metodi e Tecniche di Analisi delle Esperienze di Malattia Dipartimento di Scienze della Formazione e Psicologia, Università degli Studi di Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392908
- Sponsor's protocol ID
- Communication in oncology
- Status last verified
- Sep 2025
- First submitted
- 5 May 2020
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bury M. Chronic illness as biographical disruption. Sociol Health Illn. 1982 Jul;4(2):167-82. doi: 10.1111/1467-9566.ep11339939.
PubMed 10260456Fioretti, 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.
PubMed 27271542Giffard 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.
PubMed 23640242Habermas 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.
PubMed 10989622Jankovic, 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.
PubMed 8664044Levi 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.
PubMed 10695815Malterud 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.
PubMed 26613970McAdams, 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.
PubMed 15518671Papini, 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.
PubMed 18623217Pennebaker, J., Fracis, M.E., & Booth, R.J. (2001). Linquistic Inquiry Word Count: LIWC 2001. Mahway: Lawrence Erlbaum Associates.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Memory of Cancer Diagnosis Within Pediatric Triangle: a Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT04392908
- Acronym / sponsor ID
- Communication in oncology
- Conditions
- Memory
- Keywords
- memory, pediatric cancer, oncology, communication, diagnosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Collaborators
- University of Florence
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Communication memoryPediatric patients from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent. Knowledge of fluent Italian language is required |
| Parents | – | Other: Communication memoryParents of pediatric patients prior consent. Knowledge of fluent Italian language is required |
| Medical Staff | – | Other: Communication memoryMedical staff including doctor, psychologist and nurse |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with cancer diagnosis; their parents and healthcare staff
Key inclusion criteria (3 listed)
- age from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
- Italian speaking
- Italian speaking and signature informed consent.
Key exclusion criteria (4 listed)
- under 12 years old and above 17;
- followed by other hospital;
- cognitive disability
- cognitive disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication memoryAll groups will undergo audio-recorder interviews. Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories. | Other | Medical Staff, Parents, Patients |
Primary outcome
Phenomenological characteristics of autobiographical memory
Time frame: One day after diagnosis
Self report questionnaire "Assessment of the Phenomenology of Autobiographical Memory - APAM"
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 10260456Bury M. Chronic illness as biographical disruption. Sociol Health Illn. 1982 Jul;4(2):167-82. doi: 10.1111/1467-9566.ep11339939.
- BackgroundFioretti, C., & Smorti, A. (2015). How emotional content of memories changes in narrative. Narrative Inquire, 25(1), 37-56.
- Background: PubMed 27271542Fioretti 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.
- Background: PubMed 23640242Giffard 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.
- Background: PubMed 10989622Habermas 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.
- BackgroundJankovic, 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.
- BackgroundLancia, F. (2004). Strumenti per l'analisi dei testi: introduzione all'uso di T-Lab. Milano: Franco Angeli
- Background: PubMed 8664044Last 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.
- Background: PubMed 10695815Levi 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.
- Background: PubMed 26613970Malterud 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.
- BackgroundMcAdams, 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: PubMed 15518671Nilsson-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.
- Individual participant dataSharing planned: Undecided
Related trials for Memory
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingObservational study
Studies of Blood Flow to the Brain During Thought
Healthy Volunteer
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Fioretti, PhD study chair
Laboratorio di Metodi e Tecniche di Analisi delle Esperienze di Malattia Dipartimento di Scienze della Formazione e Psicologia, Università degli Studi di Firenze
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenomenological characteristics of autobiographical memory (time frame: One day after diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392908, which also lists 21 linked publications.
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 26 Sep 2025.