← Back to Search

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

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
Select...
I am 18 years old or older.
Select...
I can speak and understand either English or Spanish.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently receiving treatment with an immune checkpoint inhibitor.
Select...
I am currently only being treated with hormone therapy for my condition.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptom Severity/Toxicity Index
Secondary outcome measures
Incidence of Unscheduled Health Services Usage
Other outcome measures
Cost
Patient financial burden
Practice personnel time to address weekly interactive voice response (IVR) symptom reports
+1 more

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
~4010

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
236 Previous Clinical Trials
101,759 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,484 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
Alla SikorskiiPrincipal InvestigatorNRG Oncology
~344 spots leftby Feb 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top