Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04594096
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Telehealth visits Behavioral: Standard of Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 telehealth visits with a medical provider (either an MD or NP) after last chemotherapy administration in the cycle, or as otherwise indicated
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Treatment-Related Symptom Management in Adolescents and Young Adults
Actual Study Start Date : September 30, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04594096


Contacts
Layout table for location contacts
Contact: Crystal Romero 916-734-0489 ccromero@ucdavis.edu

Locations
Layout table for location information
United States, California
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Crystal Romero    916-734-0489    ccromero@ucdavis.edu   
Principal Investigator: Elysia Alvarez, MD, MPH         
Sponsors and Collaborators
University of California, Davis
Additional Information:
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04594096    
Other Study ID Numbers: 1575166
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No