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.
PRACTICES: All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.
PRACTICES: Administer oral therapy to at least 40 patients per year that meet protocol eligibility criteria.
PRACTICES: Completion and submission of the NRG-CC012CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit [CTSU] website).
PRACTICES: Having a social worker licensed in behavioral counseling or other person eligible for behavioral licensing in the practice's state or territory (if licensure is required by state or territory) who can be trained to deliver TIPC or willingness of practice to work with TIPC intervener contracted by the study team. Note: If the practice's social worker or other behavioral health professional is trained to deliver TIPC, they will be compensated for their time training and delivering the TIPC intervention.
PRACTICES: Active telephone symptom management program at the practice that is beyond symptom and oral agent adherence monitoring.
PATIENTS: Only receiving treatment with sex hormone inhibitors.
PATIENTS: Enrollment in the intervention arm of another symptom management trial at intake into the trial. Participation in lifestyle trials with primary outcomes other than symptoms is acceptable.
PATIENTS: Currently receiving regular behavioral counseling for psychological symptoms. Regular behavioral counseling is defined as at least two counseling sessions with a behavioral health care provider scheduled within the past two months. Patients who completed behavioral counseling within 2 months prior to registration are eligible. Behavioral counseling for issues other than psychological symptoms (e.g., as part of weight loss or smoking cessation program) is not an exclusion criterion.
Parallel
Counseling
Other interventionReceive TIPC
Health Education
BehavioralReceive handbook
Interview
Other interventionAncillary studies
Medical Chart Review
Other interventionAncillary studies
Monitoring
Other interventionReceive IVR symptom monitoring
Questionnaire Administration
Other interventionAncillary studies
Symptom severity/toxicity index
Toxicity index across 24 symptoms will be measured using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Linear mixed effects or generalized linear mixed effects models will be used.
Unscheduled health services
Questions with yes/no responses about each type of unscheduled health service use: hospitalizations, use of urgent care, use of the emergency department. If yes, number of days spent in the hospital, number of times visited urgent care or emergency department are recorded.
Practice personnel time to address weekly interactive voice response (IVR) symptom reports
Practice personnel time to address weekly IVR symptom reports will be determined based on the checklist of action and standard time to complete each action (e.g., 20 minutes to prescribe a medication). Standard times will be determined based on consensus of practice personnel as discussed during a meeting with practices. Total time will be prorated by the number of patients on trial during each month within each practice.
Automated symptom monitoring and telephone interpersonal counseling (TIPC) delivery at the practice (Feasibility)
Assessed using the 4-item Feasibility of Intervention Measure asked for the automated telephone system and separately for the TIPC. A higher total score indicates greater feasibility.
Practice personnel's actions on symptom reports
Practice personnel will select items for actions taken that includes symptom-related oncology visits, oral agent treatment alterations, prescriptions of supportive care medications, and referrals to supportive care services for each patient.
Treatment fidelity
Treatment fidelity will be assessed using time spent by TIPC interveners in the automated telephone symptom management +TIPC arm and fidelity scores from the checklist that indicates time spent on calls, issues discussed, and any problems encountered for TIPC protocol.
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