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Behavioral Intervention

Telephone Symptom Monitoring for Cancer

N/A

Recruiting

Led By Alla Sikorskii

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years for practice personnel

Ability to speak and understand English or Spanish for patients

Must not have

Current treatment with immune checkpoint inhibitor for patients

Only receiving treatment with sex hormone inhibitors for patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares different methods of monitoring and managing symptoms in people receiving oral anti-cancer treatment. The goal is to reduce symptom burden and psychological distress, such as depressive and anxiety symptoms, which can lead

Who is the study for?

This trial is for practices administering oral cancer therapy to at least 40 patients yearly, affiliated with NCORP. Involved personnel must be adults who consent to the study and can include a licensed social worker or equivalent for counseling. Practices must enroll 8 patients in 6 months and act on IVR reports.

What is being tested?

The trial compares three methods of symptom monitoring: IVR, ATSM with an educational handbook, and TIPC targeting psychological distress. It aims to reduce symptoms and distress in those undergoing oral anti-cancer treatment by evaluating different support strategies.

What are the potential side effects?

Since this trial focuses on non-medical interventions like monitoring and counseling, traditional side effects are not applicable. However, participants may experience varying levels of comfort or emotional response to the different types of communication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can speak and understand either English or Spanish.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment with an immune checkpoint inhibitor.

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I am currently only being treated with hormone therapy for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Symptom Severity/Toxicity Index

Secondary study objectives

Incidence of Unscheduled Health Services Usage

Other study objectives

Cost

Patient financial burden

Practice personnel time to address weekly interactive voice response (IVR) symptom reports

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II - Automated Telephone Symptom Management (ATSM), TIPCExperimental Treatment6 Interventions

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 Telephone Interpersonal Counseling (TIPC) calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.

Group II: Arm I - Interactive Voice Response (IVR) MonitoringActive Control4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education

2014

Completed Phase 3

~4410

0 / 5Eligibility criteria met