Lung CancerNCT04772118
Improving Cancer Outcomes Through Personalized Care Planning and Symptom Management.
A study testing Carevive PROmpt™ in people with Lung Cancer and Breast Cancer, run by Carevive Systems, Inc. at 1 site in United States.
Trial summary
This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Breast Cancer, Gynecologic Cancer
- What is being tested?
- Carevive PROmpt™
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2021to 1 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must be 18 years of age or older.
- Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
- Patients must have completed their navigation visit and received a Treatment Care Plan.
- Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
- Subjects must be starting or receiving treatment.
- All participants must be able to understand English.
Who cannot join
- Any patient who cannot understand written or spoken English.
- Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment
This Study is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.
- Conditions
- Lung Cancer, Breast Cancer, Gynecologic Cancer
- Being tested
- Carevive PROmpt™
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carevive PROmpt™Other
Patient Reported Outcomes Mobile Patient (Carevive PROmpt™), a digital cancer symptom monitoring platform.
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects.
Data collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits.
Outcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment.
Prevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.
Measured: 10 months
Secondary outcomes (2)
Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.
Aim 2 is to describe patient satisfaction with care experience and satisfaction with treatment decision.
Patient satisfaction with care experience and satisfaction with treatment decision will be measured with the Patient Satisfaction Survey (Appendix E). This survey is derived from the Survey of Patient Experiences with Cancer Care Survey (i.e., the Cancer CAHPS) which was developed specifically for cancer patients and is used to evaluate satisfaction with care in the Oncology Care Model (OCM). Surveys will be completed by intervention patients at the three months visit (by paper or electronically) or from home (electronically or by phone administered by the RC) if no visit is planned.
Measured: 10 months
Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.
Aim 3 is to determine feasibility/usability of the electronic treatment planning and symptom assessment for the intervention arm only.
Feasibility will be determined by the number of patients enrolled compared to the number of patients approached, and of those declined the reasons for the decline.
Usability will be determined by the results of the patient satisfaction survey.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start16 Feb 2021
- Primary completion7 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carevive Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772118
- Sponsor's protocol ID
- G423 Multi TP
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Outcomes Through Personalized Care Planning and Symptom Managment
- ClinicalTrials.gov ID
- NCT04772118
- Acronym / sponsor ID
- G423 Multi TP
- Conditions
- Lung Cancer, Breast Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Carevive Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 26 Feb 2021 (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 is a case control Study conducted with 100 patients with a solid tumor cancer diagnosis (lung, breast, or gynecologic cancer). Records of 50 patients who received treatment plans as standard of care will be abstracted for control data. 50 patients undergoing cancer treatment will receive a treatment plan and report symptoms using Carevive PROmPT™.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants must be 18 years of age or older.
- Subject participants must have a diagnosis of a breast, lung, or gynecologic cancer.
- Patients must have completed their navigation visit and received a Treatment Care Plan.
- Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
- Subjects must be starting or receiving treatment.
Key exclusion criteria (3 listed)
- Any patient who cannot understand written or spoken English.
- Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
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 |
|---|---|---|
| Carevive PROmpt™Patient Reported Outcomes Mobile Patient (Carevive PROmpt™), a digital cancer symptom monitoring platform. | Other | – |
Primary outcome
Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months.
Time frame: 10 months
Aim 1 is to compare treatment side effect frequency and intensity and patient treatment adherence between Intervention and Control subjects. Data collection for this Aim includes side effect frequency and intensity and time on treatment. Patients in the intervention arm will complete the Core Assessment prior to enrollment as standard of care. They will be enrolled to use the Carevive PROmpt™ platform to access from home. Patients will be instructed to report symptoms once a week between clinic visits. Outcomes measures for this Aim are the prevalence and severity of symptoms in each group, adherence to symptom reporting from home in intervention participants, and time on treatment from enrollment to 3 months after enrollment. Prevalence will be determined by the number of symptom alerts per patient over 3 months/ Severity will be determined by the number of mild, moderate, severe, and very severe over 3 months.
2 secondary outcomes
Outcomes for Secondary Aim 2 - 50 intervention patients will complete the Patient Satisfaction Survey at the 3month timepoint to measure satisfaction with treatment decision and care experience.
Time frame: 10 months
Outcomes for Secondary Aim 3 - Feasibility will be measured by completion of the patient questionnaires and patient symptom reports by the 50 intervention patients. Usability will be measured through provider feedback.
Time frame: 10 months
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 18 Jan 2022.
- 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.
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 Carevive PROmpt™ in people with Lung Cancer and Breast Cancer, run by Carevive Systems, Inc. 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 6 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 18 Jan 2022. 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?
Outcomes for Primary Aim 1 - 50 intervention participants with a diagnosis for lung, breast or ovarian cancer measuring the prevalence and severity of 18 different symptoms reported from home over 3 months. (time frame: 10 months). 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 18 Jan 2022.