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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908020
• Other study ID #: FOLLOWUP_PTSD
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: January 18, 2025

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Rosanna Martin, MSc
• Phone: 055 5662475
• Email: rosanna.martin[@]meyer.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 18, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Follow-up Care
• Pediatric Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital	Firenze

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	demographic data	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.	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.