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

Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
NRG Oncology
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT06279013
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.
Intervention
Counseling, Health Education, Interview, Medical Chart Review, Monitoring, Questionnaire Administration
Condition
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Investigators
Alla Sikorskii, Site Public Contact, Vamsi K. Vasireddy, Andrew J. Huang, Luis J. Santos Reyes, John E. Doster, Thomas E. Lad, Matthew F. Hudson, Sharad A. Ghamande, Harmony Bowles, Shahzad Siddique, Jay W. Carlson

See list of participating sites