CNS Qualitative Interview

Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors

Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment.

Study Overview

• Status: Recruiting
• Conditions: Central Nervous System Cancer
• Intervention / Treatment: Behavioral: Qualitative Interviews

Detailed Description

Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment. The team will conduct qualitative interviews with a diverse group of patients and families considering treatment for new and recurrent CNS tumors to determine challenges surrounding treatment and study enrollment that may be modifiable through community, hospital, and University of Colorado Cancer Center resources. The team will then assess the impact of these resources on decision making through follow-up interviews.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Wendy Moore; Phone Number: 17207776353; Email: wendy.moore@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Wendy Moore; Phone Number: 720-777-6353; Email: wendy.moore@childrenscolorado.org
      • Principal Investigator: Adam Green
      • Sub-Investigator: Claire Fraley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parents and caregivers will be eligible for participation if their child is newly diagnosed with or has had a recent relapse of a CNS tumor that will require further therapy. Therapy may be either standard of care or dictated by an open clinical trial.

For patients 12 years of age and younger, caregivers only will be included in the interviews. For patients 13-17 years of age, caregivers will have the option to include the patient in the interviews. For patients 18 years of age and older, patients will have the option to include their caregivers in the interviews.

Description

Inclusion Criteria:

1. Be the parent or caregiver of a child or young adult receiving treatment at CHCO

   a. Child must meet one criterion below: i. Newly diagnosed with a CNS tumor ii. Relapse of a CNS tumor requiring further therapy. Therapy may be standard of care of dictated by an open clinical trial

2. Patient 18 years of age or older a. Must meet one of the criteria below: i. Newly diagnosed with a CNS tumor ii. Relapse of a CNS tumor requiring further therapy. Therapy may be standard of care of dictated by an open clinical trial

Exclusion Criteria:

• Does not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with CNS Tumors; feasibility study of family interviews of those who are making decisions about treatment for newly diagnosed or relapsed CNS tumors. For patients 12 years of age and younger, caregivers only will be included in the interviews. For patients 13-17 years of age, caregivers will have the option to include the patient in the interviews. For patients 18 years of age and older, patients will have the option to include their caregivers in the interviews.

Behavioral: Qualitative Interviews; Conduct qualitative interviews with patients and families who are considering treatment options for new or recurrent CNS tumors to identify specific barriers to full participation in treatment and clinical trial enrollment (e.g., transportation, childcare, ancillary expenses). Qualitative interviews will be structured to comprehensively address potential barriers but also open-ended to give patients and families freedom to discuss a wide range of challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify barriers to trial enrollment	Qualitative interviews with patients and families who are considering treatment options for new or recurrent CNS tumors to identify specific barriers to full participation in treatment and clinical trial enrollment (e.g., transportation, childcare, ancillary expenses). Qualitative interviews will be structured to comprehensively address potential barriers but also open-ended to give patients and families freedom to discuss a wide range of challenges.	12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado
• Investigators: Principal Investigator: Adam Green, Children's Hospital Colorado

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): July 23, 2024
• Study Completion (Estimated): July 23, 2025

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 21-3870.cc; NCI-2021-14424 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No