NCT05219149

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

January 20, 2022

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

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.

Patients with CNS Tumors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Adam Green

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 20, 2022

First Posted

February 1, 2022

Study Start

January 3, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 26, 2026

Record last verified: 2026-08

Locations