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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-04886 | Registry Identifier | NCI Clinical Trial Registration Program |
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IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.
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This study is being conducted to learn more about the patient/family experience when opting to enroll in Phase I clinical trials and their quality of life (QOL) while receiving experimental therapy. Palliative care (PC) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of PC into the care of patients enrolled on experimental clinical trials.
Primary Objective
Eligible Parent Research Participants (PRPs) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. The interview can be conducted in person, over the phone, or WebEx/Zoom (audio only). The interview will last about 30 to 60 minutes. PRPs can opt to complete interviews immediately or at a scheduled date that is convenient to the PRP.
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative assessment of patient and family experience | Qualitative analysis of interviews done with parents of children with cancer who are enrolling in phase 1 studies will be performed. Broad thematic domains will be identified through a rigorous review of transcript data, with the development of codes to delineate conceptual categories. Domains will be further sub-stratified as text analysis progresses in order to identify new themes and formulate new concepts and theories. To enhance construct validity and reliability of identified domains, data will be audited by an expert panel of PPC investigators with proficiency in communication-based research, including both clinicians and researchers. Coding schemata will remain flexible to accommodate expansion of the list as the PI and expert panel agree on new code additions. Following the well-described processes of disassembling and reassembling coding categories, emerging themes will be categorized and refined, with the ultimate goal of theory-building. | Up to approximately 8 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Those who meet the Inclusion criteria and consent to participate
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| Name | Affiliation | Role |
|---|---|---|
| Erica Kaye, MD, MPH | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute/National Institutes of Health | Bethesda | Maryland | 20892 | United States | ||
| St. Jude Children's Research Hospital |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| Memphis |
| Tennessee |
| 38105 |
| United States |