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

NCT04908020 | Completed

• 1 other identifier: FOLLOWUP_PTSD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Cancer; Follow-up Care

Keywords

post-traumatic stress; coping; pediatric cancer; follow-up

Outcome Measures

Primary Outcomes (3)

• post traumatic stress symptoms

  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).

  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.

• coping strategies type_12-17

  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).

  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 strategies type_9-11

  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.

  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 (1)

• demographic data

  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.

Study Arms (1)

Follow up

The group is made up by children and adolescents, aged from 9 to 17, who received a cancer diagnosis, who completed oncological treatment and who are included in a clinical follow-up program since less than 3 years. Furthermore, the study involves one parent for each patient to collect demographics and clinical data.

Other: Follow-up patients

Interventions

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.

Follow up

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Cognitive and/or developmental impairment

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital

Florence, 50139, Italy

Location

Related Publications (14)

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  PMID: 10080546 BACKGROUND

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  PMID: 19795402 BACKGROUND

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  PMID: 11271757 BACKGROUND

• Duran B. Posttraumatic growth as experienced by childhood cancer survivors and their families: a narrative synthesis of qualitative and quantitative research. J Pediatr Oncol Nurs. 2013 Jul-Aug;30(4):179-97. doi: 10.1177/1043454213487433. Epub 2013 May 8.

  PMID: 23657991 BACKGROUND

• Kangas M. DSM-5 Trauma and Stress-Related Disorders: Implications for Screening for Cancer-Related Stress. Front Psychiatry. 2013 Oct 2;4:122. doi: 10.3389/fpsyt.2013.00122. No abstract available.

  PMID: 24106482 BACKGROUND

• Koutna V, Jelinek M, Blatny M, Kepak T. Predictors of Posttraumatic Stress and Posttraumatic Growth in Childhood Cancer Survivors. Cancers (Basel). 2017 Mar 16;9(3):26. doi: 10.3390/cancers9030026.

  PMID: 28300764 BACKGROUND

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  PMID: 7321033 BACKGROUND

• Phipps S, Long A, Hudson M, Rai SN. Symptoms of post-traumatic stress in children with cancer and their parents: effects of informant and time from diagnosis. Pediatr Blood Cancer. 2005 Dec;45(7):952-9. doi: 10.1002/pbc.20373.

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• Phipps S, Steele R. Repressive adaptive style in children with chronic illness. Psychosom Med. 2002 Jan-Feb;64(1):34-42. doi: 10.1097/00006842-200201000-00006.

  PMID: 11818584 BACKGROUND

• Scrignaro M, Barni S, Magrin ME. The combined contribution of social support and coping strategies in predicting post-traumatic growth: a longitudinal study on cancer patients. Psychooncology. 2011 Aug;20(8):823-31. doi: 10.1002/pon.1782. Epub 2010 Jun 3.

  PMID: 20878872 BACKGROUND

• Sposito AM, Silva-Rodrigues FM, Sparapani Vde C, Pfeifer LI, de Lima RA, Nascimento LC. Coping strategies used by hospitalized children with cancer undergoing chemotherapy. J Nurs Scholarsh. 2015 Mar;47(2):143-51. doi: 10.1111/jnu.12126. Epub 2015 Jan 31.

  PMID: 25639151 BACKGROUND

• Tremolada M, Bonichini S, Basso G, Pillon M. Post-traumatic Stress Symptoms and Post-traumatic Growth in 223 Childhood Cancer Survivors: Predictive Risk Factors. Front Psychol. 2016 Feb 29;7:287. doi: 10.3389/fpsyg.2016.00287. eCollection 2016.

  PMID: 26973578 BACKGROUND

• Zeltzer LK, Recklitis C, Buchbinder D, Zebrack B, Casillas J, Tsao JC, Lu Q, Krull K. Psychological status in childhood cancer survivors: a report from the Childhood Cancer Survivor Study. J Clin Oncol. 2009 May 10;27(14):2396-404. doi: 10.1200/JCO.2008.21.1433. Epub 2009 Mar 2.

  PMID: 19255309 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Stefano Stagi, MD

  Meyer Children's Hospital IRCCS

  STUDY DIRECTOR

• Rosanna Martin, MSc

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: June 1, 2021
• Study Start: January 19, 2021
• Primary Completion: March 15, 2024
• Study Completion: October 31, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

IT (1)