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Completed

NCT Number: NCT04908020

Coping and Post Traumatic Distress in Children and Adolescents During Cancer Follow-up Care

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).

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meyer Children's Hospital

Florence, 50139, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up patients

Other

The intervention consists in the assessment of some psychological aspects (post traumatic stress symptoms and coping) of cancer patients in follow-up care, through specific tests. Each patient fills out the test battery during the psychological consult. At the same time, it is involved a parent to collect personal and clinical data through an ad hoc questionnaire.

Primary outcomes

  1. post traumatic stress symptoms

    Time frame: 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.

    Trauma Symptom Checklist for Children (TSCC-A) is a self report questionnaire that assess children and adolscents' post-traumatic symptoms with 5 clinical scales: anxiety, depression, anger, post-traumatic distress, dissociation (the complete version TSCC includes sexual interest scale). It can be filled out by children and adolescents aged from 8 to 17. Each patient has to read a list of thoughts, feelings and behaviors and to rate their frequency on a 4-point Likert scale (1= never; 5= always).

  2. coping strategies type_12-17

    Time frame: 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.

    Coping Responsing Inventory (youth version; CRI-YOUTH): self report questionnaire that identify and monitor adolescents' coping strategies to manage stress. The CRI-youth assess coping strategies of youth, aged from 12 to 18, using 8 scales: these scales cover the areas of approach coping styles (Logical Analysis, Positive Reappraisal, Seeking Guidance and Support, and Problem Solving) and avoidant coping styles (Cognitive Avoidance, Acceptance or Resignation, Seeking Alternative Rewards, and Emotional Discharge).

    CRI-YOUTH is rated on a 4-point Likert scale (1= never; 5= always), with T-points from 20 to 80+ with higher scores indicating a higher usage of a coping strategy.

    Each patient had to read a list of sentences about the cognitive and behavioral responses to cope with a stressful situation and to rate their use on a 4-point Likert scale (1= never; 5= always).

  3. coping strategies type_9-11

    Time frame: 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.

    Children's Coping Strategies Checklist-Revision1 (CCSC-R1) is a self report questionnaire that identify children's coping strategies to manage stress. It contains 54 items organized in 13 subscales, loading five dimensions: problem-focused coping and positive cognitive restructuring, distraction coping strategies, avoidance coping strategies, and support-seeking strategies. Both problem-focused coping and positive cognitive restructuring are considered dimensions of active coping. Children request to assess how frequently they usually adopt the coping strategies described in the item on a 4-point Likert scale (1= never; 5= always).For each scale and subscale, the score is the mean of scores of the scale items.

Secondary outcomes

  1. demographic data

    Time frame: 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.

    The questionnaire includes a section devoted to demographics (i.e., gender, present age, age at the time of diagnosis, nationality, etc.) and to clinical data (eg. type of disease, treatments, other traumatic events, etc.). Only the parents' version contains the section related to personal and clinical data. An additional section aims to explore the thoughts, feelings and behaviour of child, adolescents and parents in the main moments of the patient's disease (communication of diagnosis, treatment, follow-up) through open and closed questions.

    Data are qualitative, no scoring, and will be helpful for cathegorization during statistical analyses.

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Coping and Post Traumatic Stress Disorder in Children and Adolescents During Cancer Follow-up Care: a Prospective Observational Cohort Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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