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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05425992
Other study ID # 21-4238.cc
Secondary ID NCI-2022-04061
Status Recruiting
Phase
First received
Last updated
Start date March 17, 2022
Est. completion date November 4, 2025

Study information

Verified date December 2023
Source University of Colorado, Denver
Contact Wendy Moore
Phone 1-720-777-6353
Email wendy.moore@childrenscolorado.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will seek to improve communication with Spanish speaking families and patients with Cancer and Blood Disorders.


Description:

The Principal Investigator seeks to improve communication with Spanish speaking families with the following goals: 1) to increase patient and family sense of inclusion in the medical community, 2) to increase patient and family medical knowledge and understanding, 3) to improve patient adherence with critical medical regimens, and ultimately, 4) to increase equality of comprehensive medical care delivery across the continuum of care including physical and psychosocial domains.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date November 4, 2025
Est. primary completion date November 4, 2024
Accepts healthy volunteers
Gender All
Age group N/A to 22 Years
Eligibility Inclusion Criteria: - 0 to 22 years of age - Diagnosis of leukemia or non-Hodgkin lymphoma - Spanish as preferred language for patient, parent or guardian - Received or receiving care at the Center for Cancer and Blood Disorders (CCBD) Exclusion Criteria: - Patients without oncologic diagnosis - Patients with parents whose language preference is English - Patients who received care solely outside of the CCBD

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interview
Patient/parent dyads expressing interest will be interviewed by a bilingual Spanish certified provider via televideo with as needed interpreter support. Interviews will be audio recorded for review and translation purposes and then will be destroyed. Interview format will be supportive and information seeking only with reassurance that purpose is for care improvement and that all answers will be evaluated without association to patient name. Interviews will then be translated and reviewed by the PI for themes regarding perceived clinic successes and perceived clinic barriers in communication or care.

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine a baseline level of Spanish speaking patient satisfaction of care Understand the patient experience using qualitative interview of Spanish speaking patients and families Determine satisfaction based on open-ended question with unsatisfied to satisfied as markers. 12 months
Primary Determine a baseline level of Spanish Speaking family satisfaction of care Understand the patient experience using qualitative interview of Spanish speaking patients and families Determine satisfaction based on open-ended question with unsatisfied to satisfied as markers. 12 months
Primary Determine effects of language barrier on Spanish speaking patient needs Understand the patient experience using qualitative interview of Spanish speaking patients and families.
Determine satisfaction based on open-ended question to determine a list or pattern of common patient needs.
12 months
Primary Determine the effect of language barrier on barriers to patient care Understand the patient experience using qualitative interview of Spanish speaking patients and families.
Determine satisfaction based on open-ended question to determine a list or pattern of common barriers to patient care.
12 months
Primary Effect of language barrier on efficiency of access to care Understand the patient experience using qualitative interview of Spanish speaking patients and families.
Determine satisfaction based on open-ended question to determine how quickly patient was able to receive care.
12 months
Secondary Determine patient interest in home telemedicine support program Open-ended questions will be used to determine level of interest in a telemedicine support program. 12 months
Secondary Determine patient interest in home telemedicine support program after discharge Open-ended questions will be used to determine level of interest in a telemedicine support program to be used after discharge from hospital. 12 months
Secondary Determine Spanish speaking patient interest in telemedical check-ins during intensive phases of therapy Open-ended questions will be used to determine level of interest in a telemedical support during treatment. 12 months
Secondary Determine Spanish speaking patient interest in medication assistance during intensive phases of therapy Open-ended questions will be used to determine level of interest in a telemedical medication support during therapy. 12 months
Secondary Determine Spanish speaking patient interest in medical check-ins during maintenance Open-ended questions will be used to determine level of interest in a telemedical check-ins during maintenance. 12 months
Secondary Determine Spanish speaking patient interest in medication assistance during maintenance Open-ended questions will be used to determine level of interest in a telemedical medication assistance during maintenance. 12 months
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