What is this study trying to find out about managing symptoms during oral anti-cancer therapy?

This study is comparing two telephone-based symptom monitoring approaches to see which better reduces symptom burden and emotional distress during oral anti-cancer treatment. It aims to find practical ways to manage symptoms and improve patient outcomes. The research is led by NRG Oncology and focuses on patients receiving oral cancer therapies.

Who may be eligible for this oral anti-cancer symptom management clinical trial?

Adults aged 18 or older who are starting or have recently started oral anti-cancer treatment, can speak English or Spanish, and have access to a telephone may be eligible. People currently receiving regular psychological counseling or pregnant at intake are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this oral anti-cancer symptom management clinical trial?

Study-related care, including symptom monitoring calls and counseling, is provided at no cost. However, personal travel or phone expenses may vary and are not guaranteed to be covered. Participants should consider their own costs when joining.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

Healthy Volunteers

ID06279013

Evaluating Telephone-Based Symptom Monitoring and Counseling for Managing Symptoms and Emotional Distress in Oral Anti-Cancer Treatment

Led by NRG Oncology · Updated on 2026-06-25

600

Participants Needed

Research Sites

65 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how different telephone-based symptom monitoring and counseling interventions affect symptom burden and psychological distress in people receiving oral anti-cancer treatments. This study compares interactive voice response IVR symptom monitoring alone versus IVR combined with an educational handbook and telephone interpersonal counseling TIPC to help reduce symptoms and emotional distress such as depression and anxiety. Managing these symptoms is important because they often cause treatment interruptions and unplanned health services use, which are common challenges in community oncology settings. Participants are assigned to one of two groups one group receives weekly IVR calls for 12 weeks to report symptoms, which are then sent to their healthcare provider the other group receives the same IVR calls plus a symptom management handbook. Those in the second group who report feeling anxious, discouraged, or sad for two consecutive weeks during the first month also receive up to 8 weeks of telephone counseling aimed at addressing psychological distress. Following the 12-week intervention, participants are monitored for an additional 5 weeks to assess sustained effects. During the study, participants will complete weekly symptom assessments via phone calls, and data on symptom severity, psychological distress, and health service use will be collected. Researchers will also evaluate the feasibility, acceptability, and cost of the interventions from the perspective of healthcare providers in community oncology practices. Follow-up assessments for practice personnel will occur at intake and at 12 and 25 months. The main outcomes focus on symptom severity through week 12 and unplanned health services through week 17.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

All participating institutions must be National Cancer Institute Community Oncology Research Program affiliates or sub-affiliates.
Practices must administer oral therapy to at least 40 eligible patients per year.
Completion and submission of the study Letter of Intent.
Practices must have or be willing to work with a licensed behavioral counselor to deliver telephone counseling if required.
Practice personnel must be 18 years or older and involved in patient care during the study.
Practice personnel delivering counseling must have or be eligible for behavioral counseling licensure.
Practice personnel must provide informed consent before study entry.
Practices must enroll at least 8 patients in the first 6 months and complete monthly symptom report action forms.
Patients must be starting or have started a new oral anti-cancer agent within 8 weeks.
Patients must be 18 years or older.
Patients must speak and understand English or Spanish.
Patients must have access to a telephone and be able to answer calls.
Patients must provide informed consent and authorize release of personal health information.

You will not qualify if you...

Practices with an active telephone symptom management program beyond symptom and oral agent adherence monitoring are excluded.
Patients receiving only sex hormone inhibitor treatments are excluded.
Patients enrolled in another symptom management trial intervention arm at intake are excluded.
Patients currently receiving regular behavioral counseling for psychological symptoms (two or more sessions in past two months) are excluded.
Patients who are pregnant at the time of trial intake are excluded.

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Evaluating Telephone-Based Symptom Monitoring and Counseling for Managing Symptoms and Emotional Distress in Oral Anti-Cancer Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria