NeoplasmsNCT03143829
Promoting Cancer Symptom Management in Older Adults
A study testing eSSET-CINV in people with Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neoplasms, Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- eSSET-CINV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2016to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women age 65 and older
- newly diagnosed with any cancer
- treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle)
- proficient in English
- have a telephone.
Who cannot join
- Patients with previous diagnosis and treatment for cancer
- advanced or end stage disease with a palliative intent
- visually or hearing impaired.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.
Read the detailed description
The goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes
- Being tested
- eSSET-CINV
- Keywords
- gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSSET-CINVOther
Also called Managing at home: CINV
This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | electronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment Receives: Other: eSSET-CINV |
| Wait Control group | Active comparator | The Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study. Receives: Other: eSSET-CINV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Severity Change Over Time
Symptom Representation Questionnaire (SRQ)[20] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome
Measured: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Self-management Behaviors Over Time
An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management.
Measured: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
Health-related Quality of Life Change Over Time
The EORTC-30[21] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
Measured: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
Resource Use Over Time
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
Measured: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start11 Aug 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either an intervention or wait control group. The intervention group receives an educational intervention at the start of the study. The wait control group receives the intervention at the end.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Florida, Orlando Health, Inc.
- Responsible party
- Sponsor
- Investigators
- Victoria Loerzel, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143829
- Sponsor's protocol ID
- 1R15NR015851-01
- Status last verified
- Dec 2021
- First submitted
- 1 May 2017
- Last updated
- 29 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Cancer Symptom Management in Older Adults
- ClinicalTrials.gov ID
- NCT03143829
- Acronym / sponsor ID
- 1R15NR015851-01
- Keywords
- gerontology, symptom self-management, Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- University of South Florida, Orlando Health, Inc.
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Posted 29 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.
Detailed description
The goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either an intervention or wait control group. The intervention group receives an educational intervention at the start of the study. The wait control group receives the intervention at the end.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: eSSET-CINVelectronic Symptom Self-Management Training- CINV (eSSET-CINV) is an educational intervention administered once at the start of treatment |
| Wait Control group | Active comparator | Other: eSSET-CINVThe Wait control group receives the electronic Symptom Self-Management Training- CINV (eSSET-CINV) at the last study visit. Outcomes will be compared to the Intervention group at the end of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men and women age 65 and older
- newly diagnosed with any cancer
- treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle)
- proficient in English
- have a telephone.
Key exclusion criteria (3 listed)
- Patients with previous diagnosis and treatment for cancer
- advanced or end stage disease with a palliative intent
- visually or hearing impaired.
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 |
|---|---|---|
| eSSET-CINVAlso: Managing at home: CINVThis intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home. | Other | Intervention group, Wait Control group |
Primary outcome
Symptom Severity Change Over Time
Time frame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported
Symptom Representation Questionnaire (SRQ)[20] , a 24-item self-report measure will be used to identify presence and severity of common treatment-related symptoms (0-10 Likert scale), including nausea and vomiting (N/V). This measure asks respondents to think about their symptoms over the past week. Higher values indicate a worse outcome
Self-management Behaviors Over Time
Time frame: data was assessed at weeks 4,7, 10, the mean number of behaviors (behaviors) combined at each time point is reported
An investigator-developed Symptom Management Checklist (SMC) will measure CINV self-management prevention behaviors. Participants will complete this daily at home between chemotherapy cycles. Higher numbers indicate more frequent management.
Health-related Quality of Life Change Over Time
Time frame: assessed at baseline (week 1), week 4, week 7, week 10. the difference between groups at week 10 is being reported
The EORTC-30[21] will measure QOL at each treatment cycle. 0-10 scale, higher scores mean better outcome
Resource Use Over Time
Time frame: assessed at weeks 4,7,10. the total number of admissions was summed across all time points and participants
Any unplanned Emergency Department or hospital admission will be recorded via participant report. Higher number indicate higher resource use.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Victoria Loerzel, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSSET-CINV in people with Neoplasms and Chemotherapy-induced Nausea and Vomiting, run by University of Central Florida 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 5 inclusion and 3 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 29 Dec 2021. 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?
Yes. Results are posted in the registry (first posted 29 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Symptom Severity Change Over Time (time frame: assessed at baseline (week 1), week 4,week 7, week 10. differences between groups at week 10 are being reported). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2021.