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

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.