CNS Qualitative Interview

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05219149
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Adam Green
Principal Investigator Affiliation Children's Hospital Colorado
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Central Nervous System Cancer
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Wendy Moore

[email protected]

720-777-6353

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