CancerNCT04594096
Improving Treatment-Related Symptom Management in Adolescents and Young Adults With Cancer
A study testing Telehealth visits in people with Cancer, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 29 years
- Conditions the study is for
- Cancer
- What is being tested?
- Telehealth visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center
Sacramento, California, 95817
About this study
Official title: Improving Treatment-Related Symptom Management in Adolescents and Young Adults
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
- Being tested
- Telehealth visits, Standard of Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth visitsBehavioural
Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle
Standard of CareBehavioural
Receiving care as usual from the UC Davis Comprehensive Cancer Center
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Telehealth visits; Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Completing the Trial
>65% of enrolled patients will complete the trial
Measured: 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
>%70% of enrolled patients will complete the survey instruments
Measured: 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)
Measured: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start30 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594096
- Sponsor's protocol ID
- 1575166
- Status last verified
- May 2024
- First submitted
- 14 Oct 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37699237
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Treatment-Related Symptom Management in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT04594096
- Acronym / sponsor ID
- 1575166
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Arm | Experimental | Behavioral: Telehealth visits, Behavioral: Standard of CareObservation 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 | Experimental | Behavioral: Telehealth visits, Behavioral: Standard of CareObservation 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). |
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth visitsReceiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle | Behavioural | Delayed Intervention Arm, Immediate Intervention Arm |
| Standard of CareReceiving care as usual from the UC Davis Comprehensive Cancer Center | Behavioural | Delayed Intervention Arm, Immediate Intervention Arm |
Primary outcome
Proportion of Patients Completing the Trial
Time frame: 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
2 secondary outcomes
Survey Response Rate
Time frame: 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)
Time frame: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 37699237Naz 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.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth visits in people with Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Completing the Trial (time frame: end of the study period (6 cycles of chemotherapy for each participant, where each cycle is 14-28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.