Clinical trial · Observational
Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): IRB approval to Close to accrual on 2-18-2025: Thematic saturation reached and enrolling further participants was deemed not necessary.
Summary
Brief summary (as posted)
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 * To qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a Phase I clinical trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Qualitative assessment of patient and family experience
- timeFrame
- Up to approximately 8 months after enrollment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Caregiver is 18 years of age or older * Caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian * If more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation * Caregiver is comfortable speaking and reading English Exclusion Criteria: * Those who do not meet inclusion criteria
References
Publications (0)
Data not yet available