How Family Coping With Child Cancer Affects Child's Quality of Life?

May 17, 2022 updated by: University Children's Hospital, Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 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.
96

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

  • Switzerland
      • Zurich, Switzerland, 8032
        • University Children's Hospital Zurich

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with newly diagnosed cancer and their parents

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Ill children with pre-existing severe cognitive and physical disability (physician's rating)
  • Ill children with single parents

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

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
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)
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 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
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)
Interview based on the University of California Los Angeles Child PTSD Reaction Index (Pynoos & Steinberg, 2013, German Version Landolt, 2014)
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)
Measured by the Symptom-Checklist-27 (SCL-27; Hardt, Egle, Kappis, Hessel, & Brähler, 2004)
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)
Measured by the Posttraumatic Diagnostic Scale (PDS, German version: Elbert et al., 2014)
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)

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.
University Children's Hospital, Zurich

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: Markus Landolt, PhD, University Children's Hospital of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
June 1, 2015

Primary Completion (Actual)

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.
October 31, 2021

Study Completion (Actual)

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 31, 2021

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).
June 10, 2015

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.
June 11, 2015

First Posted (Estimate)

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.
June 12, 2015

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.
May 18, 2022

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.
May 17, 2022

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.
May 1, 2022

More Information

Terms related to this study

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.
  • KLS-3325-02-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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