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NCT04594096 Clinical Trial

Improving Treatment-Related Symptom Management in Adolescents and Young Adults With Cancer

Cancer Clinical Trial

Official title:
Improving Treatment-Related Symptom Management in Adolescents and Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04594096
Other study ID # 1575166
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 30, 2021
Est. completion date December 31, 2023

Study information
Verified date July 2023
Source University of California, Davis
Contact Salvador Lopez
Phone 916-734-4476
Email salo@ucdavis.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the acceptability and feasibility of a telehealth intervention to improve communication between patients and medical providers in adolescent and young adult (AYA) cancer patients receiving chemotherapy treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 29 Years
Eligibility Inclusion Criteria: - Patients with cancer undergoing active treatment and who have received at least two cycles of chemotherapy - Access to Epic MyChart (we will facilitate access to MyChart for interested patients who are not yet signed up) - Access to a smartphone or tablet to access EPIC MyChart telehealth appointments Exclusion Criteria: - Non-English or non-Spanish speaking patients - Potentially completing therapy during study period (including follow-up period) or plans to leave UCDCCC during study period

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Telehealth visits
Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle
• Standard of Care
Receiving care as usual from the UC Davis Comprehensive Cancer Center

Locations
Country Name City State
United States Comprehensive Cancer Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Patients Completing the Trial >65% of enrolled patients will complete the trial end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
Secondary Survey Response Rate >%70% of enrolled patients will complete the survey instruments end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
Secondary Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) A composite score of =40 (based on 10 items with a Likert scale of 1-5 strongly disagree to strongly agree) end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
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