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Comparing Telephone Symptom Monitoring for Oral Anti-Cancer Treatment

This study is comparing different ways to help people manage symptoms and emotional distress while taking oral anti-cancer medications. It looks at three approaches: Interactive Voice Response (IVR) symptom monitoring, Automated Telephone Symptom Management (ATSM), and Telephone Interpersonal Counseling (TIPC). The goal is to see which method best reduces symptoms like depression and anxiety, which can often lead to treatment interruptions. You might be able to join if you are 18 or older, receiving oral anti-cancer treatment, and your cancer center is part of the National Cancer Institute Community Oncology Research Program (NCORP). Researchers will measure how severe your symptoms are for up to 12 weeks after starting treatment. The current status of this study is unclear, and it plans to enroll 600 participants.

Study design
This interventional study plans to enroll 600 participants. It compares the effectiveness of ATSM + TIPC against an active control group.
What's involved
You would receive either Telephone Interpersonal Counseling (TIPC), a health education handbook, or Interactive Voice Response (IVR) symptom monitoring. Ancillary studies may involve interviews and medical chart reviews. The primary endpoint is measured up to 12 weeks from the start of trial interventions.
Compensation
Not stated in the trial record.
Follow-up
Your symptom severity will be monitored for up to 12 weeks from the start of treatment, with sustained effects observed up to 17 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06279013

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

Recruiting
NAAges 18+InterventionalHealth services
NRG Oncology
~600 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:CounselingHealth EducationInterviewMedical Chart ReviewMonitoringQuestionnaire Administration

At a glance

Recruiting sites
32 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Symptom severity/toxicity index
Measured over Up to 12 weeks from the start of therapy (trial interventions)

Conditions

Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

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Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm

Where it's being run

34 sites across 12 states
South Carolina6
Wisconsin6
Illinois5
Hawaii4
Puerto Rico4
Georgia3
Arizona1
Arkansas1

Study leadership

  • Alla Sikorskii · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
720-874-1881
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
PRACTICE PERSONNEL: Age ≥ 18 years.
PRACTICE PERSONNEL: Planned to be involved in usual care for at least one enrolled patient during patient's participation in the study.
PRACTICE PERSONNEL: For a social worker or other behavioral health professional who will deliver TIPC intervention, licensure, or eligibility for licensure in behavioral counseling if required by the state or territory.
PRACTICE PERSONNEL: The practice personnel must provide study-specific informed consent prior to study entry.
RETAIN PRACTICE PARTICIPATION: In order to maintain participation in the study, practices must enroll at least 8 patients in the first 6 months (based upon the practice's monthly tracking reports) the practice is open to patient accrual to ensure that the practice can meet the accrual goals. If a practice does not meet this criterion they will be replaced.
RETAIN PRACTICE PARTICIPATION: Complete monthly forms on actions taken on IVR symptom reports. If fewer than 2 forms are completed in the first 6 months of practice's participation, practice will be replaced.
RETAIN PRACTICE PARTICIPATION: Participate in monthly study calls for the duration of practice's participation in the study.
PATIENTS: Starting a new course of an oral anti-cancer agent (the list of agents is posted to the CTSU website) other than sex hormone inhibitors, within 4 weeks after registration or have started an oral anti-cancer agent in the past 8 weeks.
PATIENTS: All concomitant medications and supportive care treatments are acceptable.
PATIENTS: Age ≥ 18 years.
PATIENTS: Able to speak and understand English or Spanish.
PATIENTS: Access to a telephone and ability to answer questions via telephone in English or Spanish.
PATIENTS: The patient must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information.

Exclusion

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.
PATIENTS: Pregnancy at intake into the trial.

What this trial measures

  • Symptom severity/toxicity indexUp to 12 weeks from the start of therapy (trial interventions)

    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.