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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412563
• Other study ID #: EPCP1
• Secondary ID: NCI-2022-04886
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2024
• Source: St. Jude Children's Research Hospital
• Contact: Erica Kaye, MD, MPH
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
United States	National Cancer Institute/National Institutes of Health	Bethesda	Maryland
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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