Breast CancerPhase 1/2NCT01108315
Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
A Phase 1/2 study testing Report symptoms via web or phone-based system in people with Breast Cancer, run by BrightOutcome at 2 sites in United States.
Trial summary
Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Report symptoms via web or phone-based system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Oct 2011
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, breast oncology patient
- Breast cancer diagnosis
- Expected chemotherapy regimen of at least 3-4 months
- Sufficient cognitive ability and psychological stability in the opinion of treating physician
- Fluent in spoken and written English
- 18 years of age or older
Show all 10Show fewer
- Outpatient
- Life expectancy > 6 months as estimated by treating physician
- Informed of the investigational nature of this study and provided informed consent.
- Has access to either a phone or the internet
Who cannot join
- Is not female, nor a breast oncology patient
- Does not have breast cancer diagnosis
- Expected chemotherapy regimen is less than 3-4 months
- Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
- Is not fluent in spoken and written English
- Is younger than 18 years of age
Show all 10Show fewer
- Inpatient
- Life expectancy < 6 months as estimated by treating physician
- Is not informed of the investigational nature of this study and does not provide informed consent.
- Does not have access to either a phone or internet.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Arizona Cancer Center
Tucson, Arizona, 85721
About this study
Official title: Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.
When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.
PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.
- Conditions
- Breast Cancer
- Being tested
- Report symptoms via web or phone-based system
- Keywords
- Patient Reported Outcomes (PRO), Web-based, Phone-based, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Report symptoms via web or phone-based systemOther
The participant reports their symptoms at least twice a week via the phone or web-based prototype system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum. Receives: Other: Report symptoms via web or phone-based system |
| Usual Care | No intervention | The participants on this arm do not record their symptoms. They report symptoms as they would under usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability and effectiveness of the prototype
Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrightOutcome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Niina Haas, BrightOutcome
- Investigators
- DerShung Yang, PhD, Principal investigator, BrightOutcomeVK Gadi, MD, Principal investigator, University of WashingtonAna Maria Lopez, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108315
- Sponsor's protocol ID
- HC4ext
- Other IDs
- NCI
- Status last verified
- Feb 2012
- First submitted
- 20 Apr 2010
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
- ClinicalTrials.gov ID
- NCT01108315
- Acronym / sponsor ID
- HC4ext
- Conditions
- Breast Cancer
- Keywords
- Patient Reported Outcomes (PRO), Web-based, Phone-based, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- BrightOutcomeIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Apr 2010 (estimated)
- 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.
Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.
When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.
PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Report symptoms via web or phone-based systemThe participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum. |
| Usual Care | No intervention | –The participants on this arm do not record their symptoms. They report symptoms as they would under usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female, breast oncology patient
- Breast cancer diagnosis
- Expected chemotherapy regimen of at least 3-4 months
- Sufficient cognitive ability and psychological stability in the opinion of treating physician
- Fluent in spoken and written English
Key exclusion criteria (10 listed)
- Is not female, nor a breast oncology patient
- Does not have breast cancer diagnosis
- Expected chemotherapy regimen is less than 3-4 months
- Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
- Is not fluent in spoken and written English
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 |
|---|---|---|
| Report symptoms via web or phone-based systemThe participant reports their symptoms at least twice a week via the phone or web-based prototype system. | Other | Intervention |
Primary outcome
Usability and effectiveness of the prototype
Time frame: 6 months
Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication
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 6 Feb 2012.
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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.
DerShung Yang, PhD principal investigator
BrightOutcome
VK Gadi, MD principal investigator
University of Washington
Ana Maria Lopez, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Report symptoms via web or phone-based system in people with Breast Cancer, run by BrightOutcome at 2 sites 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 10 inclusion and 10 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 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Usability and effectiveness of the prototype (time frame: 6 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 6 Feb 2012.