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

May 7, 2024 updated by: University of California, Davis

Improving Treatment-Related Symptom Management in Adolescents and Young Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Intervention Arm

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the immediate arm will start the intervention (telehealth visits) in Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will resume clinical care as usual.
Behavioral: Telehealth visits
Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle
Behavioral: Standard of Care
Receiving care as usual from the UC Davis Comprehensive Cancer Center
Experimental: Delayed Intervention Arm

Observation periods will be from 4 days post last administration of chemotherapy until the next chemotherapy administration.

All patients will undergo an initial observation period that will span two chemotherapy cycles and will be receiving clinical care as usual determined by the primary oncology team.

Patients enrolled on the delayed arm will receive clinical care as usual during Time Period 2 (following chemotherapy cycles 3 and 4). During Time Period 3 (following chemotherapy cycles 5 and 6), this arm will start the intervention (telehealth visits).
Behavioral: Telehealth visits
Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle
Behavioral: Standard of Care
Receiving care as usual from the UC Davis Comprehensive Cancer Center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients Completing the Trial
Time Frame: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
>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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey Response Rate
Time Frame: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
>%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)
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ)
Time Frame: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1575166

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Telehealth visits

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe