Clinical trial NCT03424343: Longitudinal Identity Study of Childhood Cancer Survivors
Official title: The Long-term Impact of Pediatric Cancer on Adolescents, Emerging Adults, and Their Family: Identity, Psychosocial Functioning, and Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Cancer
Keywords: survivors
parents
sibling
family environment
psychosocial functioning
longitudinal
cancer
identity
adolescence
emerging adulthood
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2018-02-07
Enrollment: 126
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of childhood cancer, treated at the department of pediatric oncology at UZ Leuven.

Brief 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. 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.

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?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Dimensions of Identity Development
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Identity from an Eriksonian Perspective
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Illness Centrality
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Self-Identity after Cancer
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
Secondary outcomes:
measure: Change in Post-Traumatic Stress Symptoms (measured in survivors)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Illness-related Benefit Finding (measured in survivors)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Depressive Symptoms (measured in survivors, siblings, and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Cancer-related Worries (measured in survivors and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Global Life Satisfaction (measured in survivors, siblings and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Bodily Functioning (measured in survivors)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Self-Esteem (measured in survivors, siblings, and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Resilience (measured in survivors and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Personality (measured in survivors and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Self-Harm (measured in survivors)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Perception of Control (measured in survivors, siblings, and parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Social Support (measured in survivors and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Contact with Peer Survivors (measured in survivors)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Parental Behavioral Control (measured in survivors, parents, and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Parental Responsiveness (measured in survivors, parents, and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Parental Overprotection (measured in survivors, parents, and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Parental Psychological Control (measured in survivors, parents, and siblings)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Illness Intrusiveness (measured in parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Parental competence (measured in parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Role Restriction (measured in parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Relationship Quality (measured in parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
measure: Change in Benefit Finding (measured in parents)
timeFrame: Assessed and reported at baseline, one year later, two years later, and five years later
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Gasthuisberg
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Koen Luyckx, Dr.
role: PRINCIPAL_INVESTIGATOR
References: