Pediatric CancerNCT02470975
How Family Coping With Child Cancer Affects Child's Quality of Life?
An observational study of Pediatric Cancer, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
Children with newly diagnosed cancer and their parents will be contacted and invited to participate. Upon agreement, children will be interviewed, both parents will fill out questionnaires and be additionally interviewed. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pediatric Cancer
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2015to 31 Dec 2021
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with newly diagnosed cancer and their parents
Who may be able to join
- Children between 6 and 17 years old diagnosed with cancer (4-6 weeks) as listed on the Swiss Cancer Registry
- Parents of children recently diagnosed with child cancer
- Caregiver parent living together with another partner in a committed relationship for at least one year.
Who cannot join
- Ill children with pre-existing severe cognitive and physical disability (physician's rating)
- Ill children with single parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Families Cope With Child Cancer? A Longitudinal Study on the Role of "We-appraisals" on Child's Health-related Quality of Life
Children with newly diagnosed cancer and their parents will be contacted and invited to participate. Upon agreement, children will be interviewed, both parents will fill out questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC) and parent-child DC during a course of 12 months will be examined. Additionally, during brief separate interviews, the parents' speech will be coded for we-appraisals and expressed emotion regarding the other partner and the child. Findings will provide information on how family variables affect child QoL over 12 months.
Read the detailed description
Background
Researchers and clinicians alike have been calling for family-oriented and longitudinal research on child cancer (CC). The reason for this is threefold. First, parents are the most influential context on child development. Second, CC can be considered a "we-family disease", that is, a stressor that affects the patient, their parents and the interaction within all family members and subsystems, since they are an interdependent unit. Third, the higher survivals rates and increased chronicity of CC demand an ongoing adaptation from the whole family to the illness-related stress. As such, several studies have found associations between family and child variables during and after cancer treatment, and few studies suggest a causal relationship of family functioning on child adjustment and quality of life (QoL). Nevertheless, (1) which family dimensions related with the process of stress, appraisal and coping with CC, (2) how changes and (3) divergences within those dimensions predict child QoL over time, remain answered. Research on stress and coping in couples has identified two crucial dimensions for better relational and health outcomes that have the potential to provide those answers. "We-Appraisals", which is the process how individuals tend to evaluate what happens to them as a couple, i.e., in a more relational-oriented way ("we" problem) or in a more individual way ("I/you" problem); and Dyadic Coping, i.e., the process how couples cope together with stress. Therefore, the aim to expand and understand these dimensions in the context of families coping with CC.
Aims
Using a three-wave longitudinal design, the investigators aim to examine (1) the role that parental we-appraisals and we-disease appraisals, couple and parent-child dyadic coping have for a child's QoL over time, (2) how these variables change over time and how these changes predict changes in a child's QoL, (3) how congruence or discrepancies within we-appraisals and we-disease-appraisals, couple and parent-child dyadic coping predict changes in child's QoL over time, and (4) how observed parental we-appraisals, partner's and parental ex-pressed emotion predict child' QoL.
Hypothesis
The investigators expect that higher scores on parents' variables will predict positive changes on child QoL during the first 12 months after cancer diagnosis (T2 and T3). The investigators expect that changes and discrepancies within parents' variables over time will predict changes in child QoL at T2 and T3.
Methods
One hundred children with newly diagnosed cancer and their mothers and fathers will be recruited from the University Children's Hospitals in Zurich and Berne and assessed three times during 12 months. The children will be interviewed at all time points. The parents will complete several paper-pencil questionnaires assessing the variables of interest and will be interviewed at T2 (6 months) and T3 (1 year). Latent change score models with three factors (i.e. mother, father, child) and multilevel analysis will be used to test our hypothesis.
Relevance
By providing precursor information about the role that key family dimensions play on explaining better child QoL over time, this study will enable health-care professionals to know which family resources and members should be targeted during cancer treatment, improve interventions and, ultimately, to improve child QoL.
- Conditions
- Pediatric Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Child quality of life
Interview based on the DISABKIDS Chronic Generic Measure long version (DCGM-37) (Ravens-Sieberer et al., 2007)
Measured: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Secondary outcomes (3)
Child posttraumatic stress disorder
Interview based on the University of California Los Angeles Child PTSD Reaction Index (Pynoos \& Steinberg, 2013, German Version Landolt, 2014)
Measured: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Parental psychological adjustment
Measured by the Symptom-Checklist-27 (SCL-27; Hardt, Egle, Kappis, Hessel, \& Brähler, 2004)
Measured: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Parental posttraumatic stress disorder
Measured by the Posttraumatic Diagnostic Scale (PDS, German version: Elbert et al., 2014)
Measured: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Landolt, PhD, Principal investigator, University Children's Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470975
- Sponsor's protocol ID
- KLS-3325-02-2014
- Status last verified
- May 2022
- First submitted
- 10 Jun 2015
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Families Cope With Child Cancer? A Longitudinal Study on the Role of "We-appraisals" on Child's Health-related Quality of Life
- ClinicalTrials.gov ID
- NCT02470975
- Acronym / sponsor ID
- KLS-3325-02-2014
- Conditions
- Pediatric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
Children with newly diagnosed cancer and their parents will be contacted and invited to participate. Upon agreement, children will be interviewed, both parents will fill out questionnaires and be additionally interviewed. Using a 3-wave longitudinal design, mainly self-reported parental we-appraisals and we-disease-appraisals, couple dyadic coping (DC) and parent-child DC during a course of 12 months will be examined. Additionally, during brief separate interviews, the parents' speech will be coded for we-appraisals and expressed emotion regarding the other partner and the child. Findings will provide information on how family variables affect child QoL over 12 months.
Detailed description
Background
Researchers and clinicians alike have been calling for family-oriented and longitudinal research on child cancer (CC). The reason for this is threefold. First, parents are the most influential context on child development. Second, CC can be considered a "we-family disease", that is, a stressor that affects the patient, their parents and the interaction within all family members and subsystems, since they are an interdependent unit. Third, the higher survivals rates and increased chronicity of CC demand an ongoing adaptation from the whole family to the illness-related stress. As such, several studies have found associations between family and child variables during and after cancer treatment, and few studies suggest a causal relationship of family functioning on child adjustment and quality of life (QoL). Nevertheless, (1) which family dimensions related with the process of stress, appraisal and coping with CC, (2) how changes and (3) divergences within those dimensions predict child QoL over time, remain answered. Research on stress and coping in couples has identified two crucial dimensions for better relational and health outcomes that have the potential to provide those answers. "We-Appraisals", which is the process how individuals tend to evaluate what happens to them as a couple, i.e., in a more relational-oriented way ("we" problem) or in a more individual way ("I/you" problem); and Dyadic Coping, i.e., the process how couples cope together with stress. Therefore, the aim to expand and understand these dimensions in the context of families coping with CC.
Aims
Using a three-wave longitudinal design, the investigators aim to examine (1) the role that parental we-appraisals and we-disease appraisals, couple and parent-child dyadic coping have for a child's QoL over time, (2) how these variables change over time and how these changes predict changes in a child's QoL, (3) how congruence or discrepancies within we-appraisals and we-disease-appraisals, couple and parent-child dyadic coping predict changes in child's QoL over time, and (4) how observed parental we-appraisals, partner's and parental ex-pressed emotion predict child' QoL.
Hypothesis
The investigators expect that higher scores on parents' variables will predict positive changes on child QoL during the first 12 months after cancer diagnosis (T2 and T3). The investigators expect that changes and discrepancies within parents' variables over time will predict changes in child QoL at T2 and T3.
Methods
One hundred children with newly diagnosed cancer and their mothers and fathers will be recruited from the University Children's Hospitals in Zurich and Berne and assessed three times during 12 months. The children will be interviewed at all time points. The parents will complete several paper-pencil questionnaires assessing the variables of interest and will be interviewed at T2 (6 months) and T3 (1 year). Latent change score models with three factors (i.e. mother, father, child) and multilevel analysis will be used to test our hypothesis.
Relevance
By providing precursor information about the role that key family dimensions play on explaining better child QoL over time, this study will enable health-care professionals to know which family resources and members should be targeted during cancer treatment, improve interventions and, ultimately, to improve child QoL.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with newly diagnosed cancer and their parents
Key inclusion criteria (3 listed)
- Children between 6 and 17 years old diagnosed with cancer (4-6 weeks) as listed on the Swiss Cancer Registry
- Parents of children recently diagnosed with child cancer
- Caregiver parent living together with another partner in a committed relationship for at least one year.
Key exclusion criteria (2 listed)
- Ill children with pre-existing severe cognitive and physical disability (physician's rating)
- Ill children with single parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Child quality of life
Time frame: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Interview based on the DISABKIDS Chronic Generic Measure long version (DCGM-37) (Ravens-Sieberer et al., 2007)
3 secondary outcomes
Child posttraumatic stress disorder
Time frame: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Parental psychological adjustment
Time frame: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
Parental posttraumatic stress disorder
Time frame: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)
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 18 May 2022.
- Principal Investigator web-siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Markus Landolt, PhD principal investigator
University Children's Hospital of Zurich
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, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 3 inclusion and 2 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 18 May 2022. 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 Switzerland. 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?
Child quality of life (time frame: Three time points in a 12- months trajectory: 4/6 weeks after cancer diagnosis (T1), 6 months after diagnosis 1 (T2), and 12 months after diagnosis (T3)). 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 18 May 2022.