Clinical trial · Interventional
Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
Telephone Linked Care for Cancer Symptom Management
NCT01979146CI-TRIAL-00026210completedN/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 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.
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 |
|---|---|---|---|
| Provider Unrelieved Symptom Alert | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Provider Unrelieved Symptom Alert
- description
- 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.
- interventionNames
- Other: Provider Unrelieved Symptom Alert
- type
- NO_INTERVENTION
- label
- Attentional Control Usual Care Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.