Clinical trial · Interventional
Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
NCT01973946CI-TRIAL-00026220completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Symptom Alert and Coaching | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Patients 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.
- type
- EXPERIMENTAL
- label
- Symptom Alert and Coaching
- description
- Patients 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (3)
- DERIVEDMooney 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. PMID 39042843
- DERIVEDMoraitis 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. PMID 38558321
- DERIVEDMooney 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. PMID 28135050