Exploring The Role Of Palliative Care In Phase 1 Enrolled Pediatric Oncology Patients

NCT05412563 | Terminated

• 2 other identifiers: EPCP1NCI-2022-04886
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Quality of Life

Keywords

Palliative Care; Pediatric Oncology Patients; Caregiver; Phase I studies; Associated Distress; Hopes; Worries

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those who meet the Inclusion criteria and consent to participate

You may qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (2)

National Cancer Institute/National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study Officials

• Erica Kaye, MD, MPH

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: September 1, 2022
• Primary Completion: December 18, 2024
• Study Completion: February 18, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

US (2)