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

NCT04594096 | Completed

• 1 other identifier: 1575166
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survey Response Rate

  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)

  end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)

Study Arms (2)

Immediate Intervention Arm

EXPERIMENTAL

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; Behavioral: Standard of Care

Delayed Intervention Arm

EXPERIMENTAL

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; Behavioral: Standard of Care

Interventions

Telehealth visits BEHAVIORAL

Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle

Delayed Intervention Arm; Immediate Intervention Arm

Standard of Care BEHAVIORAL

Receiving care as usual from the UC Davis Comprehensive Cancer Center

Delayed Intervention Arm; Immediate Intervention Arm

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Related Publications (1)

• Naz H, Apesoa-Varano EC, Romero C, Keegan T, Malogolowkin M, Callas C, Gosdin M, Alvarez E. How Do Adolescent and Young Adult Patients with Cancer Manage Their Chemotherapy-Related Symptoms at Home? J Adolesc Young Adult Oncol. 2023 Dec;12(6):923-928. doi: 10.1089/jayao.2022.0153. Epub 2023 Sep 12.

  PMID: 37699237 DERIVED

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 telehealth visits with a medical provider (either an MD or NP) after last chemotherapy administration in the cycle, or as otherwise indicated

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: September 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

US (1)