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Pediatric CancerLInCNCT03424343

Longitudinal Identity Study of Childhood Cancer Survivors

An observational study of Pediatric Cancer, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Read more about this study

Who is it for?
Ages 14 to 25 years
Conditions the study is for
Pediatric Cancer
What is being tested?
Questionnaire bundle and Obtaining information from survivors' medical file
How many people
126 participants
Where
1 siteBelgium
Study dates
28 Aug 2018to 31 Dec 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 14 to 25 years
  • All sexes
  • Child, Adult

Study population: Survivors of childhood cancer, treated at the department of pediatric oncology at UZ Leuven.

Who may be able to join

  • Survivors of childhood leukemia/lymphoma, solid tumors, and brain tumors, of whom the treatment has ended.
  • 14-25 years at the start of the study
  • Treated at the department of pediatric oncology at University Hospital Leuven, Belgium.
  • Sufficient knowledge of Dutch

Who cannot join

  • Mental retardation which hinders completion of the questionnaire bundle
  • Younger than 14 year and older than 25 year
  • Physically incapable to complete the questionnaire bundle
  • Insufficient knowledge of Dutch
  • Contact information is not available

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Gasthuisberg

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: The Long-term Impact of Pediatric Cancer on Adolescents, Emerging Adults, and Their Family: Identity, Psychosocial Functioning, and Development

The study investigators plan to conduct a longitudinal questionnaire study in adolescents and emerging adults (14-25 years of age at the start of the study) who survived childhood cancer to chart their identity development and broader social functioning. Additionally, the functioning of these survivors will be related to the functioning of their parents and siblings. The investigators shall focus especially on the current experience and impact of the earlier cancer experience. They will investigate to what extent the experience of a life-threatening disease has an effect on the daily life of survivors and over time and how the survivors develop through the course of adolescence and emerging adulthood on the psychosocial level. The formation of an adult identity is a very challenging task during adolescence and the way to adulthood and the fact that these youth had cancer during their childhood may especially complicate this process of identity formation. Furthermore, both parental and sibling functioning will be taken into account, which will allow us to examine inter-generational mechanisms (thus parental functioning that possibly impacts youth functioning and vice versa) and sibling functioning in these families. To investigate the latter, at each timepoint of the longitudinal study a sibling between 14 and 25 years of age at the start of the study will be included (if there is more than one sibling in a family, ideally the sibling who is closest in age will be the one who participates in the study). Moreover, a community sample that is matched on age and sex with the survivor of pediatric cancer will be assessed. This will allow the investigators to make well-founded comparisons regarding identity development and broader psychosocial functioning.

Read the detailed description

In the present longitudinal study, four main research questions will be investigated.

  1. How does identity develop in cancer survivors? Based on previous findings from studies in identity development, it seems that young adults with a chronic disease like type 1 diabetes show less exploration or consider less identity possibilities from which they can choose, e.g. they dwell less upon the choice of education. Does this finding also apply to survivors of childhood cancer or are these youth more similar to a community sample? This research question may provide an answer to the question whether or not there is a continued (psychological) impact of childhood cancer on the later identity development of survivors. For this purpose the investigators shall make use of an identity model which was developed at their research department and which has gained much international research attention. In addition, the investigators want to look at illness-identity, which comprises the amount to which the earlier cancer experience is integrated into one's identity. Does the youngster feel still engulfed by the earlier cancer experience, or has he/she integrated this experience as part of his/her self-concept? Or does the youngster feel even enriched by the earlier cancer experience, thus did he/she end up even stronger through the experience?
  2. How do survivors of pediatric cancer and/or their parents function on the psychological level, more specific on the level of life satisfaction and depressive symptoms, and what is the role of identity and personality variables herein? This question examines, among other factors, concepts like benefit-finding, post-traumatic growth, resilience,... Thereby it would be interesting to examine whether different subgroups can be identified, for example, which groups of persons display less adaptive functioning and why?
  3. Are there certain parenting dimensions (e.g. overprotection, responsiveness, psychological control,...) which are more prevalent in families that were confronted with pediatric cancer and are these dimensions differently related to the psychosocial adaptation of survivors? Does this relate to certain aspects of survivor functioning, like depressive symptoms and quality of life? Thereby, transactional processes between survivor and parental functioning will be investigated, e.g. does identity development of survivors have an impact on parental well-being, and has parental well-being in turn an impact on survivor functioning? Taken together, the investigators want to investigate to what extent these contextual variables determine the functioning of adolescents and emerging adults.
  4. What is the impact for siblings of cancer survivors? How do they go through their identity process? Do they experience the same parenting as the survivors experience themselves? E.g if survivors would experience more parental overprotection, would siblings experience overprotection to the same extent?
Being tested
Questionnaire bundle, Obtaining information from survivors' medical file
Keywords
survivors, parents, sibling, family environment, psychosocial functioning, longitudinal, cancer, identity, adolescence, emerging adulthood
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire bundleOther

    Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later.

  • Obtaining information from survivors' medical fileOther

    After obtaining informed consent, we will access the medical file of participants to obtain information on the diagnosis, time of diagnosis, treatment duration, type of treatment, and relapse (when applicable).

Study groups in NCT03424343
Study groupRoleWhat they receive
cancer survivor, parents, siblingstudy samples adolescent and young adult survivors of pediatric cancer, their parents, and one sibling; they are assessed using self-report questionnaires, so no intervention takes place
Receives: Other: Questionnaire bundle; Other: Obtaining information from survivors' medical file

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Dimensions of Identity Development

    Dimensions of Identity Development Scale (DIDS); dimensions: commitment making (range: 5 - 25), Identification with Commitment (range: 5 - 25), Exploration in Breadth (rang: 5 - 25), Exploration in Depth (range: 5 - 25), Ruminative Exploration (range: 5 - 25); for each dimension, a higher score indicates more identification with the dimension

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  2. Change in Identity from an Eriksonian Perspective

    Erikson Psychosocial Stage Inventory (EPSI); subscales: Synthesis (range: 5 - 30), Confusion (range: 5 - 30); for each scale, higher scores indicate more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  3. Change in Illness Centrality

    Illness Centrality; total scale range: 0 - 4; A higher score indicates more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  4. Change in Self-Identity after Cancer

    Self-Identity after Cancer; dimensions: victim of cancer (range: 1 - 5), cancer patient (range: 1 - 5), person who had cancer (range: 1 - 5), survivor (range: 1 - 5); for each dimension, a higher score indicates more identification with the dimension

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

Secondary outcomes (22)
  1. Change in Post-Traumatic Stress Symptoms (measured in survivors)

    Children's Revised Impact of Event Scale (CRIES-13); total scale range: 0 - 65; Higher scores indicate more sensitivity for PTSD; A score higher than 30 possibly indicates the presence of PTSD; subscales: Intrusion (range: 0 - 20), Avoidance (range: 0 - 20), Arousal (range: 0 - 25); Higher scores indicate more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  2. Change in Illness-related Benefit Finding (measured in survivors)

    Benefit scale from the Benefit and Burden Scale (BBSC); total scale range: 10 - 50; A higher score indicates more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  3. Change in Depressive Symptoms (measured in survivors, siblings, and parents)

    Center for Epidemiologic Studies Depression (CES-D-12); total scale range: 0 - 36; a higher score indicates the presence of more depressive symptoms

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  4. Change in Cancer-related Worries (measured in survivors and parents)

    Cancer Related Worries Scale; total scale range: 4 - 20; A higher score indicates the presence of more cancer-related worries

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  5. Change in Global Life Satisfaction (measured in survivors, siblings and parents)

    Satisfaction with Life Scale (SWLS); total scale range: 5 - 35; A higher score indicates more satisfaction with life

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  6. Change in Bodily Functioning (measured in survivors)

    Short Form 36, physical subscale (SF-36); total scale range: 10 - 30: A higher score indicates worse bodily functioning

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  7. Change in Self-Esteem (measured in survivors, siblings, and parents)

    Rosenberg Self-Esteem Scale (RSES); total scale range: 10 - 40: A higher score indicates higher self-esteem

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  8. Change in Resilience (measured in survivors and parents)

    Brief Resilience Scale (BRS); total scale range: 6 - 30; A higher score corresponds to being more resilient

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  9. Change in Personality (measured in survivors and siblings)

    Big Five Inventory 10 (BFI-10); subscales: Extraversion (range: 2 - 10), Agreeableness (range: 2 - 10), Conscientiousness (range: 2 - 10), Neuroticism (range: 2 - 10), Openness (range: 2 - 10); for each scale, a higher score indicates more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  10. Change in Self-Harm (measured in survivors)

    Based on Goossens et al., 2013: Health risk behaviors in adolescents and emerging adults with congenital heart disease: psychometric properties of the Health Behavior Scale-Congenital Heart Disease

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  11. Change in Perception of Control (measured in survivors, siblings, and parents)

    Multidimensional Health Locus of Control Scale (MHLCS): subscales: Internal Health Locus of Control (range 6 - 36), Powerful Others Health Locus of Control (range 6 - 36), Chance Health Locus of Control (range: 6 - 36); for each scale, a higher score indicates more identification with the scale

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  12. Change in Social Support (measured in survivors and siblings)

    Multidimensional Scale of Perceived Social Support (MSPSS); subscales: support from special someone (range: 4 - 28), support from family (range: 4 - 28), support from friends (range: 4 - 28); for each subscale, a higher score indicates more support

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  13. Change in Contact with Peer Survivors (measured in survivors)

    Self-constructed questionnaire

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  14. Change in Parental Behavioral Control (measured in survivors, parents, and siblings)

    Based on the 8-item Parental Expectations for Behavior Scale and the 8-item Parental Monitoring of Behavior Scale uit de 'Parental Regulation Scale - Youth Self-Report' (PRS -YSR; Barber, 2002); Behavioral Control; total scale range: 7 - 35; A higher score indicates more parental behavioral control

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  15. Change in Parental Responsiveness (measured in survivors, parents, and siblings)

    Child Report of Parent Behavior Inventory (CRPBI; Schaefer, 1965; Schludermann \& Schludermann, 1988); Responsiveness; total scale range: 7 - 35; A higher score indicates more parental responsiveness

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  16. Change in Parental Overprotection (measured in survivors, parents, and siblings)

    based on Dutch Multidimensional Overprotective Parenting Scale, Kins \& Soenens, 2013; Overprotection / anxious parenting; Overprotection; total scale range: 8 - 40; A higher score indicates more parental overprotection

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  17. Change in Parental Psychological Control (measured in survivors, parents, and siblings)

    8-item Psychological Control Scale-Youth Self-Report ( Barber, 1996); Psychological Control; total scale range: 8 - 40; A higher score indicates more parental psychological control

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  18. Change in Illness Intrusiveness (measured in parents)

    Illness Intrusiveness Questionnaire Parent Report (IIQ-Parent Report); total scale range: 13 - 91; A higher score indicates more illness intrusiveness

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  19. Change in Parental competence (measured in parents)

    Parenting Stress Index - Sense of Competence Scale; total scale range: 13 - 78; A higher score indicates a lower sense of parental competence

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  20. Change in Role Restriction (measured in parents)

    Parental Burden Questionnaire, subscale role restriction; total scale range: 6 - 24; A higher score indicates a greater sense of role restriction

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  21. Change in Relationship Quality (measured in parents)

    Family Functioning Questionnaire, subscale parental relationship quality; total scale range: 5 - 20; A higher score indicates a greater sense of partner relationship quality

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

  22. Change in Benefit Finding (measured in parents)

    Benefit Finding Scale; total scale range: 15 - 105; A higher score indicates more benefit finding

    Measured: Assessed and reported at baseline, one year later, two years later, and five years later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start28 Aug 2018
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
Prospective
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424343
Sponsor's protocol ID
S60535
Acronym
LInC
Status last verified
Aug 2024
First submitted
29 Nov 2017
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Cancer, run by KU Leuven at 1 site in Belgium.

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 5 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 20 Oct 2026. 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 Belgium. 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?

Change in Dimensions of Identity Development (time frame: Assessed and reported at baseline, one year later, two years later, and five years later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Oct 2026.

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