protocolSection identificationModule nctId: NCT06279013, orgStudyIdInfo id: NRG-CC012CD, secondaryIdInfos id: NCI-2023-10831, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: NRG Oncology, secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: DCP, secondaryIdInfos id: NRG-CC012CD, type: OTHER, domain: CTEP, secondaryIdInfos 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-16, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: NRG Oncology, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule 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., conditionsModule conditions: Hematopoietic and Lymphoid System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomized, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Interviewers will be blinded to the study arm; IVR is automated., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 516, type: ESTIMATED, armsInterventionsModule interventions name: Counseling, interventions name: Health Education, interventions name: Interview, interventions name: Medical Chart Review, interventions name: Monitoring, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Symptom Severity/Toxicity Index, secondaryOutcomes measure: Incidence of Unscheduled Health Services Usage, otherOutcomes measure: Practice personnel time to address weekly interactive voice response (IVR) symptom reports, otherOutcomes measure: Treatment fidelity, otherOutcomes measure: Cost, otherOutcomes measure: Patient financial burden, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False