Longitudinal Identity Study of Childhood Cancer Survivors (LInC)

August 20, 2024 updated by: Koen Luyckx, KU Leuven

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Gasthuisberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
cancer survivor, parents, sibling
study 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
Other: Questionnaire bundle
Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later.
Other: Obtaining information from survivors' medical file
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Dimensions of Identity Development
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Identity from an Eriksonian Perspective
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Illness Centrality
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Illness Centrality; total scale range: 0 - 4; A higher score indicates more identification with the scale
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Self-Identity after Cancer
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Post-Traumatic Stress Symptoms (measured in survivors)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Illness-related Benefit Finding (measured in survivors)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Benefit scale from the Benefit and Burden Scale (BBSC); total scale range: 10 - 50; A higher score indicates more identification with the scale
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Depressive Symptoms (measured in survivors, siblings, and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Center for Epidemiologic Studies Depression (CES-D-12); total scale range: 0 - 36; a higher score indicates the presence of more depressive symptoms
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Cancer-related Worries (measured in survivors and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Cancer Related Worries Scale; total scale range: 4 - 20; A higher score indicates the presence of more cancer-related worries
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Global Life Satisfaction (measured in survivors, siblings and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Satisfaction with Life Scale (SWLS); total scale range: 5 - 35; A higher score indicates more satisfaction with life
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Bodily Functioning (measured in survivors)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Short Form 36, physical subscale (SF-36); total scale range: 10 - 30: A higher score indicates worse bodily functioning
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Self-Esteem (measured in survivors, siblings, and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Rosenberg Self-Esteem Scale (RSES); total scale range: 10 - 40: A higher score indicates higher self-esteem
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Resilience (measured in survivors and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Brief Resilience Scale (BRS); total scale range: 6 - 30; A higher score corresponds to being more resilient
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Personality (measured in survivors and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Self-Harm (measured in survivors)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Perception of Control (measured in survivors, siblings, and parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Social Support (measured in survivors and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Contact with Peer Survivors (measured in survivors)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Self-constructed questionnaire
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Parental Behavioral Control (measured in survivors, parents, and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Parental Responsiveness (measured in survivors, parents, and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Parental Overprotection (measured in survivors, parents, and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Parental Psychological Control (measured in survivors, parents, and siblings)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
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
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Illness Intrusiveness (measured in parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Illness Intrusiveness Questionnaire Parent Report (IIQ-Parent Report); total scale range: 13 - 91; A higher score indicates more illness intrusiveness
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Parental competence (measured in parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Parenting Stress Index - Sense of Competence Scale; total scale range: 13 - 78; A higher score indicates a lower sense of parental competence
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Role Restriction (measured in parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Parental Burden Questionnaire, subscale role restriction; total scale range: 6 - 24; A higher score indicates a greater sense of role restriction
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Relationship Quality (measured in parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Family Functioning Questionnaire, subscale parental relationship quality; total scale range: 5 - 20; A higher score indicates a greater sense of partner relationship quality
Assessed and reported at baseline, one year later, two years later, and five years later
Change in Benefit Finding (measured in parents)
Time Frame: Assessed and reported at baseline, one year later, two years later, and five years later
Benefit Finding Scale; total scale range: 15 - 105; A higher score indicates more benefit finding
Assessed and reported at baseline, one year later, two years later, and five years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitaire Ziekenhuizen KU Leuven
Research Foundation Flanders

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Koen Luyckx, Dr., KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S60535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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