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CNS Qualitative Interview

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05219149
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment
Central Nervous System Cancer 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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors
Actual Study Start Date : January 3, 2022
Estimated Primary Completion Date : July 23, 2023
Estimated Study Completion Date : July 23, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Identify barriers to trial enrollment [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05219149


Contacts
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Contact: Wendy Moore 17207776353 wendy.moore@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Wendy Moore    720-777-6353    wendy.moore@childrenscolorado.org   
Principal Investigator: Adam Green         
Sub-Investigator: Claire Fraley         
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
Investigators
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Principal Investigator: Adam Green Children's Hospital Colorado
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05219149    
Other Study ID Numbers: 21-3870.cc
NCI-2021-14424 ( Other Identifier: CTRP )
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases