Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Communication Memory of Cancer Diagnosis Within the Pediatric Triangle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392908
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborator:
University of Florence
Information provided by (Responsible Party):
Rosanna Martin, Meyer Children's Hospital

Tracking Information
First Submitted Date May 5, 2020
First Posted Date May 19, 2020
Last Update Posted Date May 19, 2020
Actual Study Start Date September 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2020)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Communication Memory of Cancer Diagnosis Within the Pediatric Triangle
Official Title Communication Memory of Cancer Diagnosis Within Pediatric Triangle: a Cross-sectional Observational Study
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.
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:

  1. Sample recruitment and informed consent collection.
  2. Diagnosis communication audio recording.
  3. Communication of the autobiographical memory of the diagnosis audio recording of patients, parents, oncologist, nurse and psychologists involved, the day after the communication.
  4. Questionnaire APAM administration for adult participants.
  5. Audio Transcription and data coded. Data will be registered and operated by means of statistical software as SPSS (IBM) and T-Lab (Lancia, 2004).
  6. 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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with cancer diagnosis; their parents and healthcare staff
Condition Memory
Intervention Other: Communication memory
All groups will undergo audio-recorder interviews. Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
Study Groups/Cohorts
  • 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
    Intervention: Other: Communication memory
  • Parents
    Parents of pediatric patients prior consent. Knowledge of fluent Italian language is required
    Intervention: Other: Communication memory
  • Medical Staff
    Medical staff including doctor, psychologist and nurse
    Intervention: Other: Communication memory
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 13, 2020)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Rosanna Martin, MSc 055 5662475 ext 0039 rosanna.martin@meyer.it
Contact: Laura Vagnoli, MSc 055 5662719 ext 0039 laura.vagnoli@meyer.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04392908
Other Study ID Numbers Communication in oncology
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rosanna Martin, Meyer Children's Hospital
Study Sponsor Meyer Children's Hospital
Collaborators University of Florence
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
PRS Account Meyer Children's Hospital
Verification Date May 2020