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CancerNCT01973946

Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up

A study testing Symptom Alert and Coaching in people with Cancer, run by University of Utah at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Symptom Alert and Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
2 sitesUnited States
Study dates
Sep 2007to Apr 2012
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 (age 18 or over)
  • Have a histological diagnosis of cancer
  • a life expectancy of at least 3 months and cognitively able to participate
  • Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
  • care is under the direction of one of the 8 designated provider teams;
  • English speaking;
  • has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.

Who cannot join

  • patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
  • patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
  • Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.

Read the detailed description

The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns. For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms. The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment. The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner. On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns. The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness \& tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue. Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group. Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.

Conditions
Cancer
Being tested
Symptom Alert and Coaching
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.

  • Symptom Alert and CoachingOther

    Patients heard self-care messages when they reported a symptom was present. The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily. The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.

Study groups in NCT01973946
Study groupRoleWhat they receive
Usual CareNo interventionPatients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms. The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions. Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner. Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.
Symptom Alert and CoachingExperimentalPatients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines.
Receives: Other: Symptom Alert and Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient reported symptom levels

    During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.

    Measured: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.

Secondary outcomes (5)

  1. Medical Encounters Telephone Interview

    Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization. If they reported they did have a medical encounter, the research staff would call and 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.

    Measured: Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.

  2. Patient reported symptom related interference with daily activities

    This is a one item question asked daily during the symptom monitoring call about the level of interference their symptoms had on their daily activities (0-10 scale).

    Measured: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.

  3. SF-36 Functional Status

    Functional status was measured monthly using the SF-36.

    Measured: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.

  4. Work interference

    For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.

    Measured: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.

  5. Work Limitations Questionnaire

    The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.

    Measured: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startSep 2007
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01973946
Sponsor's protocol ID
17472
Other IDs
5R01CA120558
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

Publications

  • Mooney K, Beck SL, Wilson C, Coombs L, Whisenant M, Moraitis AM, Sloss EA, Alekhina N, Lloyd J, Steinbach M, Nicholson B, Iacob E, Donaldson G. Assessing Patient Perspectives and the Health Equity of a Digital Cancer Symptom Remote Monitoring and Management System. JCO Clin Cancer Inform. 2024 Jul;8:e2300243. doi: 10.1200/CCI.23.00243.

    PubMed 39042843

  • Moraitis AM, Iacob E, Wong B, Beck SL, Echeverria C, Donaldson G, Mooney K. Pairing automated exercise coaching with patient-reported symptom monitoring: A way to nudge exercise uptake during cancer treatment? Support Care Cancer. 2024 Apr 1;32(4):258. doi: 10.1007/s00520-024-08450-1.

    PubMed 38558321

  • Mooney KH, Beck SL, Wong B, Dunson W, Wujcik D, Whisenant M, Donaldson G. Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. Cancer Med. 2017 Mar;6(3):537-546. doi: 10.1002/cam4.1002. Epub 2017 Jan 30.

    PubMed 28135050

Questions about this trial

What is this clinical trial studying?

A study testing Symptom Alert and Coaching in people with Cancer, run by University of Utah 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 7 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 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.

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 (time frame: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.). 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 NCT01973946, which also lists 3 linked publications.

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.

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