Pediatric CancerNCT04908020
Coping and Post Traumatic Distress in Children and Adolescents During Cancer Follow-up Care
An observational study of Pediatric Cancer and Follow-up Care, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Pediatric Cancer, Follow-up Care
- What is being tested?
- Follow-up patients
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2021to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patients in cancer follow-up care since less than 3 years
- Scheduled to follow-up appointement
- Italian speaking
- Patients' and parents' consent
Who cannot join
- Cognitive and/or developmental impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coping and Post Traumatic Stress Disorder in Children and Adolescents During Cancer Follow-up Care: a Prospective Observational Cohort Study
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).
Read the 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.
- Conditions
- Pediatric Cancer, Follow-up Care
- Being tested
- Follow-up patients
- Keywords
- post-traumatic stress, coping, pediatric cancer, follow-up
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Follow-up patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start19 Jan 2021
- Primary completion15 Mar 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Martin, Meyer Children's Hospital IRCCS
- Investigators
- Stefano Stagi, MD, Study director, Meyer Children's Hospital IRCCSRosanna Martin, MSc, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908020
- Sponsor's protocol ID
- FOLLOWUP_PTSD
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision has to be shared with the Clinical Trial Office of the Hospital
Publications
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.
PubMed 10080546Briere 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.
PubMed 18404627Cloitre 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.
PubMed 19795402Compas 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.
PubMed 11271757Duran 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.
PubMed 23657991Kangas 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.
PubMed 24106482Koutna 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.
PubMed 28300764Billings 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.
PubMed 7321033Phipps 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.
PubMed 15806541Phipps 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.
PubMed 11818584Scrignaro 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.
PubMed 20878872Sposito 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.
PubMed 25639151Tremolada 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.
PubMed 26973578Zeltzer 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.
PubMed 19255309
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping and Post Traumatic Stress Disorder in Children and Adolescents During Cancer Follow-up Care: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04908020
- Acronym / sponsor ID
- FOLLOWUP_PTSD
- Conditions
- Pediatric Cancer, Follow-up Care
- Keywords
- post-traumatic stress, coping, pediatric cancer, follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up | – | Other: Follow-up patientsThe 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. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Patients in cancer follow-up care since less than 3 years
- Scheduled to follow-up appointement
- Italian speaking
- Patients' and parents' consent
Key exclusion criteria (1 listed)
- Cognitive and/or developmental impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up patientsThe 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. | Other | Follow up |
Primary outcome
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).
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).
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Background: PubMed 10080546Bremner 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.
- Background: PubMed 18404627Briere 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.
- Background: PubMed 19795402Cloitre 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.
- Background: PubMed 11271757Compas 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.
- Background: PubMed 23657991Duran 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.
- Background: PubMed 24106482Kangas 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.
- Background: PubMed 28300764Koutna 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.
- Background: PubMed 7321033Billings 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.
- Background: PubMed 15806541Phipps 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.
- Background: PubMed 11818584Phipps 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.
- Background: PubMed 20878872Scrignaro 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.
- Background: PubMed 25639151Sposito 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.
- Individual participant dataSharing planned: Undecided. Decision has to be shared with the Clinical Trial Office of the Hospital
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Stagi, MD study director
Meyer Children's Hospital IRCCS
Rosanna Martin, MSc principal investigator
Meyer Children's Hospital IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer and Follow-up Care, run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04908020, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.