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

NCT ID: NCT04594096

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Telehealth visits

Intervention Type BEHAVIORAL

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

Standard of Care

Intervention Type BEHAVIORAL

Receiving care as usual from the UC Davis Comprehensive Cancer Center

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).

Group Type EXPERIMENTAL

Telehealth visits

Intervention Type BEHAVIORAL

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

Standard of Care

Intervention Type BEHAVIORAL

Receiving care as usual from the UC Davis Comprehensive Cancer Center

Interventions

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Telehealth visits

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

Intervention Type BEHAVIORAL

Standard of Care

Receiving care as usual from the UC Davis Comprehensive Cancer Center

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37699237 (View on PubMed)

Related Links

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Other Identifiers

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1575166

Identifier Type: -

Identifier Source: org_study_id

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