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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Telehealth visits
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Arm<br>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<br>* Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle<br>Behavioral: Standard of Care<br>* Receiving care as usual from the UC Davis Comprehensive Cancer Center<br>|
| Experimental: Delayed Intervention Arm<br>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<br>* Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle<br>Behavioral: Standard of Care<br>* Receiving care as usual from the UC Davis Comprehensive Cancer Center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |