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

NCT ID: NCT04908020

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-19

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer Follow-up Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Follow-up patients

Intervention Type 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.

Interventions

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Follow-up patients

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meyer Children's Hospital IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Rosanna Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefano Stagi, MD

Role: STUDY_DIRECTOR

Meyer Children's Hospital IRCCS

Rosanna Martin, MSc

Role: PRINCIPAL_INVESTIGATOR

Meyer Children's Hospital IRCCS

Locations

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Meyer Children's Hospital

Florence, , Italy

Site Status

Countries

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Italy

References

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Bremner JD. Acute and chronic responses to psychological trauma: where do we go from here? Am J Psychiatry. 1999 Mar;156(3):349-51. doi: 10.1176/ajp.156.3.349. No abstract available.

Reference Type BACKGROUND
PMID: 10080546 (View on PubMed)

Briere J, Kaltman S, Green BL. Accumulated childhood trauma and symptom complexity. J Trauma Stress. 2008 Apr;21(2):223-6. doi: 10.1002/jts.20317.

Reference Type BACKGROUND
PMID: 18404627 (View on PubMed)

Cloitre M, Stolbach BC, Herman JL, van der Kolk B, Pynoos R, Wang J, Petkova E. A developmental approach to complex PTSD: childhood and adult cumulative trauma as predictors of symptom complexity. J Trauma Stress. 2009 Oct;22(5):399-408. doi: 10.1002/jts.20444. Epub 2009 Sep 30.

Reference Type BACKGROUND
PMID: 19795402 (View on PubMed)

Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.

Reference Type BACKGROUND
PMID: 11271757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23657991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24106482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28300764 (View on PubMed)

Billings AG, Moos RH. The role of coping responses and social resources in attenuating the stress of life events. J Behav Med. 1981 Jun;4(2):139-57. doi: 10.1007/BF00844267.

Reference Type BACKGROUND
PMID: 7321033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15806541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11818584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20878872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25639151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26973578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19255309 (View on PubMed)

Other Identifiers

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FOLLOWUP_PTSD

Identifier Type: -

Identifier Source: org_study_id

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