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

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT04594096

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 indicated2 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 :

Sep 30, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Dec 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

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

Proportion of Patients Completing the Trial [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

Survey Response Rate [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
Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) [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

Criteria

Ages Eligible for Study:

12 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Comprehensive Cancer Center	Sacramento	California	United States	95817

Sponsors and Collaborators

University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Learn more or sign up for the study here!

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT04594096

Other Study ID Numbers:

1575166

First Posted:

Oct 20, 2020

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 10, 2021