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

May 5, 2026 updated by: NRG Oncology

Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

In this clinical trial, symptom monitoring (interactive voice response [IVR] is compared to automated telephone symptom management [ATSM] and telephone interpersonal counseling [TIPC]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamón, Puerto Rico, 00961
        • Recruiting
        • Puerto Rico Hematology Oncology Group
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
          • Site Public Contact
          • Phone Number: 787-780-2865
      • Manati, Puerto Rico, 00674
        • Recruiting
        • Doctors Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 787-621-4397
        • Principal Investigator:
          • Luis J. Santos Reyes
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • Centro Comprensivo de Cancer de UPR
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • PROncology
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Georgia
      • Albany, Georgia, United States, 31701
        • Recruiting
        • Phoebe Putney Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Sharad A. Ghamande
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
      • Augusta, Georgia, United States, 30901
        • Recruiting
        • Augusta Oncology Associates PC-D'Antignac
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
          • Site Public Contact
          • Phone Number: 706-821-2944
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Cancer Cenrer - POB I
        • Contact:
          • Site Public Contact
          • Phone Number: 808-532-0315
        • Principal Investigator:
          • Karen Rowan
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Karen Rowan
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Queen's Cancer Center - Kuakini
        • Contact:
          • Site Public Contact
          • Phone Number: 808-531-8521
        • Principal Investigator:
          • Karen Rowan
      • ‘Ewa Beach, Hawaii, United States, 96706
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Contact:
        • Principal Investigator:
          • Karen Rowan
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • John H Stroger Jr Hospital of Cook County
        • Contact:
          • Site Public Contact
          • Phone Number: 312-864-5204
        • Principal Investigator:
          • Deimante M. Tamkus
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Vamsi K. Vasireddy
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Principal Investigator:
          • Amelia M. Jernigan
        • Contact:
    • Missouri
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Harmony Bowles
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health Cancer Center
        • Contact:
        • Principal Investigator:
          • John E. Doster
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Evan M. Graboyes
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Matthew F. Hudson
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Principal Investigator:
          • Matthew F. Hudson
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Matthew F. Hudson
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Principal Investigator:
          • Matthew F. Hudson
        • Contact:
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Medford, Wisconsin, United States, 54451
        • Recruiting
        • Aspirus Medford Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Aspirus Cancer Care - James Beck Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (IVR monitoring)
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.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Other: Monitoring
Receive IVR symptom monitoring
Other Names:
  • monitor
Experimental: Arm II (ATSM, TIPC)
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.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Other: Monitoring
Receive IVR symptom monitoring
Other Names:
  • monitor
Other: Counseling
Receive TIPC
Other Names:
  • Counseling Intervention
Behavioral: Health Education
Receive handbook

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom severity/toxicity index
Time Frame: Up 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.
Up to 12 weeks from the start of therapy (trial interventions)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unscheduled health services
Time Frame: Up to 17 weeks from the start of therapy (trial interventions)
Questions with yes/no responses about each type of unscheduled health service use: hospitalizations, use of urgent care, use of the emergency department. If yes, number of days spent in the hospital, number of times visited urgent care or emergency department are recorded.
Up to 17 weeks from the start of therapy (trial interventions)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: Up to 5 years
Total costs (fixed and variable), including personnel time, fixed costs to develop software, and operating costs for the interventions will be calculated. Cost savings in each arm will be calculated using unadjusted and adjusted rates of hospitalizations and urgent care or emergency department visits based on cost data for the States where participating practices will be located.
Up to 5 years
Practice personnel time to address weekly interactive voice response (IVR) symptom reports
Time Frame: Up to 25 months
Practice personnel time to address weekly IVR symptom reports will be determined based on the checklist of action and standard time to complete each action (e.g., 20 minutes to prescribe a medication). Standard times will be determined based on consensus of practice personnel as discussed during a meeting with practices. Total time will be prorated by the number of patients on trial during each month within each practice.
Up to 25 months
Automated symptom monitoring and telephone interpersonal counseling (TIPC) delivery at the practice (Feasibility)
Time Frame: Up to 25 months
Assessed using the 4-item Feasibility of Intervention Measure asked for the automated telephone system and separately for the TIPC. A higher total score indicates greater feasibility.
Up to 25 months
Practice personnel's actions on symptom reports
Time Frame: Up to 25 months
Practice personnel will select items for actions taken that includes symptom-related oncology visits, oral agent treatment alterations, prescriptions of supportive care medications, and referrals to supportive care services for each patient.
Up to 25 months
Treatment fidelity
Time Frame: Up to 25 months
Treatment fidelity will be assessed using time spent by TIPC interveners in the automated telephone symptom management +TIPC arm and fidelity scores from the checklist that indicates time spent on calls, issues discussed, and any problems encountered for TIPC protocol.
Up to 25 months
Perceptions of intervention acceptability and appropriateness
Time Frame: Up to 25 months
Measured using the total score from the Acceptability of Intervention Measure and Intervention Appropriateness Measure, each with 4 questions, with higher scores indicating greater acceptability and appropriateness, respectively.
Up to 25 months
Functional Assessment of Chronic Illness Therapy - COmprehensive Score for financial Toxicity (COST)
Time Frame: Up to 17 weeks from the start of therapy (trial interventions)
The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It includes 12 items rated on a 5-point Likert type scale. The items are summarized into a total score per scoring instructions.
Up to 17 weeks from the start of therapy (trial interventions)
Concurrent treatment interaction
Time Frame: Up to 17 weeks from the start of therapy (trial interventions)
Concurrent treatments will be collected. Each concurrent treatment will be analyzed separately for the primary and secondary outcome measures.
Up to 17 weeks from the start of therapy (trial interventions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alla Sikorskii, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-CC012CD (Other Identifier: CTEP)
  • UG1CA189867 (U.S. NIH Grant/Contract)
  • NCI-2023-10831 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA279472 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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