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)
20
Enrollment
1
Location
2
Arms
15
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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 [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 [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) [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:
No
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

SiteCityStateCountryPostal Code
1UC Davis Comprehensive Cancer CenterSacramentoCaliforniaUnited States95817

Sponsors and Collaborators

  • University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 7, 2021