Clinical trial NCT04908020: Coping and Post Traumatic Distress in Children and Adolescents During Cancer Follow-up Care
Official title: Coping and Post Traumatic Stress Disorder in Children and Adolescents During Cancer Follow-up Care: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cancer
Follow-up Care
Keywords: post-traumatic stress
coping
pediatric cancer
follow-up
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population is made up by children and adolescents, aged from 9 to 17, who received a cancer diagnosis, who completed oncological treatment and who are "out of therapies". Furthermore, they have to be included in a clinical follow-up program since less than 3 years.

Brief summary: To explore the presence of post traumatic disorder and its association with coping strategies in children and adolescents during cancer follow-up care.

Hypothesis: the investigators expect a reduction of post traumatic symptoms according to adequate coping strategies (eg. approach coping styles).

Detailed description: Oncological disease in childhood or adolescence can represent a highly traumatic experience, considering its physical, psychological and social consequences in the short and long term. The literature has investigated this population both in the acute phase of the disease and at the end of the therapies to explore the potentially traumatic effects of this experience. While some studies support the non-incidence of post-traumatic symptoms related to the disease and underline a post-traumatic growth, other studies confirm a high risk of developing post-traumatic symptoms. This risk increases according to specific demographic (eg. age of diagnosis) and clinical (eg. type of disease, of treatments, etc.) characteristics. The literature also points out that these consequences can be mediated by some factors, including coping strategies, that is the way patients manage stress.

The study aims: to investigate the presence of post-traumatic symptoms in patients out of therapy and in follow-up care; to explore the possible association between this post-traumatic symptomatology and the coping strategies used by the patients; to focus the possible correlation between post traumatic symptoms, coping and the demographic and clinical characteristics of patients.

Eligibility criteria: Inclusion Criteria:

* Patients in cancer follow-up care since less than 3 years
* Scheduled to follow-up appointement
* Italian speaking
* Patients' and parents' consent

Exclusion Criteria:

- Cognitive and/or developmental impairment

Primary outcomes:
measure: post traumatic stress symptoms
timeFrame: Post-traumatic Stress Symptoms are assessed at the first psychological consult since beginning of the study, indipendently from follow up time. Is a single assessment for every partecipant.
measure: coping strategies type_12-17
timeFrame: Coping strategies are assessed at the first psychological consult since beginning of the study, indipendently from follow up time. Is a single assessment for every partecipant.
measure: coping strategies type_9-11
timeFrame: Coping strategies are assessed at the first psychological consult since beginning of the study, indipendently from follow up time. Is a single assessment for every partecipant.
Secondary outcomes:
measure: demographic data
timeFrame: Both patients and parents fill out the ad-hoc questionnaire at the first psychological consult since beginning of the study, indipendently from follow up time. Is a single assessment for every partecipant.
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Stefano Stagi, MD
role: STUDY_DIRECTOR
affiliation: Meyer Children's Hospital IRCCS
name: Rosanna Martin, MSc
role: PRINCIPAL_INVESTIGATOR
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