CancerNCT01979146
Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
A study testing Provider Unrelieved Symptom Alert in people with Cancer, run by University of Utah at 3 sites in United States.
Trial summary
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Provider Unrelieved Symptom Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2001to Mar 2004
- 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
- Adult (18 or older)
- Histological Diagnosis of Cancer
- Life Expectancy of at least 6 months
- Cognitively able to participate (verified by provider team)
- Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
- Had Poorly controlled symptoms during the first cycle of chemotherapy
Show all 10Show fewer
- Care under the direction of one of the designated provider teams
- English or Spanish speaking
- Has access to a telephone on a daily basis
- Able to use the telephone unassisted
Who cannot join
- Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
- Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
- Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Medical Center
Boston, Massachusetts, 02118
South Carolina Community Oncology Practice
Greer, South Carolina, 29650
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Telephone Linked Care for Cancer Symptom Management
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
Read the detailed description
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue. The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications. All participants called the automated system daily to report their symptom presence, severity, and distress. When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse. The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers. Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms. The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress. Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded. In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.
- Conditions
- Cancer
- Being tested
- Provider Unrelieved Symptom Alert
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider Unrelieved Symptom AlertOther
The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale). The oncology providers used their clinical judgement in terms of what they did with the information received. There was no prescribed response as part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Provider Unrelieved Symptom Alert | Experimental | Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms. The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels). Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days. Receives: Other: Provider Unrelieved Symptom Alert |
| Attentional Control Usual Care Group | No intervention | Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations. The usual care group received equivalent contact time with the automated system including identical voice and assessment questions. Data were not available for clinical action and not reported to the oncology providers. On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported symptom levels on a 0-10 scale
During daily automated calls, patients provided information about common chemotherapy symptoms.
Measured: patients report symptoms daily for the duration of the study, an expected average of 6 weeks
Secondary outcomes (3)
Medical Encounters Telephone Interview
When a patient reports during their daily phone call with the automated symptom monitoring system that they had been in contact with a health care provider, the research staff would conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored by the system.
Measured: participants will be followed for an expected average of 6 weeks
Functional Status
The SF-12 was administered monthly to measure functional status.
Measured: monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
Work Attendance
Patients who indicated at study enrollment that they planned to work during treatment answered a yes/no question during the automated symptom monitoring system call to report whether or not they worked the previous day.
Measured: reported daily, participants will be followed for an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startApr 2001
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathleen Mooney, University of Utah
- Investigators
- Kathleen H Mooney, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979146
- Sponsor's protocol ID
- 7846-00
- Other IDs
- R01CA089474
- Status last verified
- Feb 2017
- First submitted
- 22 Oct 2013
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Linked Care for Cancer Symptom Management
- ClinicalTrials.gov ID
- NCT01979146
- Acronym / sponsor ID
- 7846-00
- Conditions
- Cancer
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 8 Nov 2013 (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.
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
Detailed description
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue. The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications. All participants called the automated system daily to report their symptom presence, severity, and distress. When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse. The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers. Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms. The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress. Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded. In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Provider Unrelieved Symptom Alert | Experimental | Other: Provider Unrelieved Symptom AlertPatients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms. The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels). Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days. |
| Attentional Control Usual Care Group | No intervention | –Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations. The usual care group received equivalent contact time with the automated system including identical voice and assessment questions. Data were not available for clinical action and not reported to the oncology providers. On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult (18 or older)
- Histological Diagnosis of Cancer
- Life Expectancy of at least 6 months
- Cognitively able to participate (verified by provider team)
- Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
Key exclusion criteria (3 listed)
- Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
- Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
- Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
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 |
|---|---|---|
| Provider Unrelieved Symptom AlertThe Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale). The oncology providers used their clinical judgement in terms of what they did with the information received. There was no prescribed response as part of the intervention. | Other | Provider Unrelieved Symptom Alert |
Primary outcome
Patient reported symptom levels on a 0-10 scale
Time frame: patients report symptoms daily for the duration of the study, an expected average of 6 weeks
During daily automated calls, patients provided information about common chemotherapy symptoms.
3 secondary outcomes
Medical Encounters Telephone Interview
Time frame: participants will be followed for an expected average of 6 weeks
Functional Status
Time frame: monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
Work Attendance
Time frame: reported daily, participants will be followed for an expected average of 6 weeks
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 1 Mar 2017.
- 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.
Kathleen H Mooney, PhD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Unrelieved Symptom Alert in people with Cancer, run by University of Utah at 3 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 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Patient reported symptom levels on a 0-10 scale (time frame: patients report symptoms daily for the duration of the study, an expected average of 6 weeks). 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 1 Mar 2017.