Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The participants are being asked to take part in this research study because the participant is a child who has been diagnosed with cancer and has completed genetic testing to find out if the participant has a variant in a gene that may predispose the participant to cancer, and/or the participants are the parents (i.e., guardian/caregiver) of this child. This research is being done to understand how finding out the results of genetic testing during childhood impacts the participant and family. The investigator will compare the emotions and behavior of parents and children based on the genetic testing results.
Primary Objective
Exploratory Objectives
A mixed methods approach, including questionnaires and qualitative interviews with children and their parents. Participants ("Primary Strata:" parents (i.e., guardians/caregivers) and children age ≥ 8 years, n=132; "Parent Only Strata:" parents of children age < 8 years, n=66) will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years, n=30) with P/LP variants (and who are aware of their result status) and their parents (n=30) to obtain more open-ended information about the impact of genetic testing result disclosure, family communication about testing results, and their perception of result implications.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Group (parent-child) | parents (i.e., guardians/caregivers) and children age ≥ 8 years,will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. Optional qualitative interviews may be completed individually for participants (age ≥ 12 years with P/LP variant and aware of results, or their parent) | ||
| Parent Only Group | parents of children age < 8 years, will complete questionnaires to examine the impact of germline variant disclosure on parent adjustment, parenting, and child adjustment. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Fear of Cancer Recurrence | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Fear of Cancer Recurrence - Short Form. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Cancer Information Questionnaire for Parents | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Cancer Information Questionnaire for Parents. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Multidimensional Impact of Cancer Risk Assessment | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Multidimensional Impact of Cancer Risk Assessment. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Brief Symptom Inventory 18 | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Brief Symptom Inventory 18. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Impact of Event Scale | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Impact of Event Scale - Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. |
Not provided
Not provided
Inclusion Criteria:
Primary Strata
Parent Only Strata
Exclusion Criteria:
Not provided
Not provided
Not provided
All participants who meet eligibility criteria and consent to enrollment on the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katianne Sharp, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St.Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 |
| Psychological Adaptation to Genetic Information Scale | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Psychological Adaptation to Genetic Information Scale-Modified. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Symptom Interpretation Questionnaire-Parent Report | Independent two-sample t-tests will assess statistical parental adjustment differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the Symptom Interpretation Questionnaire-Parent Report. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Parent-Adolescent Communication Scale | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) of parent- and child-reports on the Parent-Adolescent Communication Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Family Environment Scale | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Family Environment Scale-Revised. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Parental Bonding Instrument | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the child-reported Parental Bonding Instrument. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Parent Protection Scale | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Parent Protection Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Openness to Discuss Cancer in the Family | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Openness to Discuss Cancer in the Family. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Child Vulnerability Scale | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Child Vulnerability Scale. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |
| Adult Responses to Children's Symptoms | Independent two-sample t-tests will assess statistical parenting differences between group means (i.e., parents of children with pathologic/likely pathologic vs. negative genetic testing result) on the parent-reported Adult Responses to Children's Symptoms. Only in the situation of outliers, two-sample Mann-Whitney U tests will be used for testing purposes. | Day 0 |