NCT06279013

Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. Test the effectiveness of Automated Telephone System Management (ATSM) + Telephone Interpersonal Counseling (TIPC) versus active control on patient-level outcome of the summary toxicity index of 24 Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms that include depressive, anxiety, and other symptoms commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect) and 13-17 (sustained effect). SECONDARY OBJECTIVE: I. Test the effectiveness of ATSM+TIPC versus active control on patient-level outcome of unscheduled health services over weeks 1-12 and 13-17. EXPLORATORY OBJECTIVES: I. Evaluate implementation outcomes at the practice personnel level (physicians, nurses, nurse practitioners, advanced practice providers, physician assistants, medical assistants, pharmacists, social workers, and other behavioral health professionals): Ia. Feasibility of implementation of the automated telephone symptom monitoring and TIPC at the community oncology practice. Ib. Perceptions of acceptability of the automated telephone symptom monitoring and TIPC for the community oncology practice. Ic. Perceptions of appropriateness of the automated telephone symptom monitoring and TIPC for the community oncology practice. II. Estimate delivery cost of the ATSM+TIPC and active control and cost savings for the ATSM+TIPC versus active control as a result of reduced unscheduled health services use. III. Estimate the effect of the ATSM+TIPC versus active control on patient-reported financial burden. IV. Estimate the differences in the effect of the ATSM+TIPC versus active control on the primary and secondary outcomes according to concurrent administration of oral agent with immune checkpoint inhibitor, other targeted infusion therapy, infusion chemotherapy, or radiation therapy. OUTLINE: Practices are randomized to 1 of 2 arms. ARM I: Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes. ARM II: Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes. After completion of study intervention, patients are followed up during weeks 13-17 and practice personnel are assessed at intake and 12 and 25 months later.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Counseling	Receive TIPC
BEHAVIORAL	Health Education	Receive handbook
OTHER	Interview	Ancillary studies
OTHER	Medical Chart Review	Ancillary studies
OTHER	Monitoring	Receive IVR symptom monitoring
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-10-14
• Primary completion: 2027-02-01
• Completion: 2028-05-01
• First posted: 2024-02-26
• Last updated: 2026-02-13

Locations

34 sites across 2 countries: United States, Puerto Rico