nctId: NCT06279013 id: NRG-CC012CD id: NCI-2023-10831 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: NRG-CC012CD type: OTHER domain: NRG Oncology id: NRG-CC012CD type: OTHER domain: DCP id: NRG-CC012CD type: OTHER domain: CTEP id: R01CA279472 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279472 briefTitle: Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06-16 date: 2027-02-01 date: 2028-05-01 date: 2024-02-26 date: 2024-02-28 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) briefSummary: In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes. conditions: Hematopoietic and Lymphoid System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Interviewers will be blinded to the study arm; IVR is automated. whoMasked: OUTCOMES_ASSESSOR count: 516 type: ESTIMATED name: Counseling name: Health Education name: Interview name: Medical Chart Review name: Monitoring name: Questionnaire Administration measure: Symptom Severity/Toxicity Index measure: Incidence of Unscheduled Health Services Usage measure: Practice personnel time to address weekly interactive voice response (IVR) symptom reports measure: Treatment fidelity measure: Cost measure: Patient financial burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False