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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Telehealth visits; Behavioral: Standard of Care

• Registration Number: NCT04594096
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Study Start: 2021-09-30
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Intervention Arm	Standard of Care	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.
Delayed Intervention Arm	Telehealth visits	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).
Immediate Intervention Arm	Telehealth visits	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.
Delayed Intervention Arm	Standard of Care	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States