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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Crystal Romero; 916-734-0489; ccromero@ucdavis.edu

Locations

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

More Information

Additional Information:

Learn more or sign up for the study here! 

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04594096
• Other Study ID Numbers: 1575166
• First Posted: October 20, 2020
• Last Update Posted: November 10, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No