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Hematopoietic and Lymphatic System NeoplasmSYMONNCT06279013

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

A study testing Counseling, Health Education and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by NRG Oncology at 34 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Counseling, Health Education and Interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
34 sitesin 2 countries
Study dates
14 Oct 2024to 1 Jun 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

34 sites in 2 countries

United States30 sites, 30 recruiting

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706

    Site Public Contact, rohta@queens.org

    Karen Rowan

    Recruiting

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

    Site Public Contact, 229-312-0405, ga_cares@augusta.edu

    Anand P. Jillella

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Harmony Bowles

    Recruiting

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

    Site Public Contact, 864-512-4651, rhonda.ballew@anmedhealth.org

    Jay B. Nayak

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

    Site Public Contact, 706-821-2944

    Anand P. Jillella

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    Anand P. Jillella

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Evan M. Graboyes

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Site Public Contact, 312-864-5204

    Deimante M. Tamkus

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

    Site Public Contact, 913-948-5588, aroland@kccop.org

    Jay W. Carlson

    Recruiting

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Matthew F. Hudson

    Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Matthew F. Hudson

    Recruiting

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Matthew F. Hudson

    Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Matthew F. Hudson

    Recruiting

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-532-0315

    Karen Rowan

    Recruiting

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

    Site Public Contact, 808-545-8548

    Karen Rowan

    Recruiting

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

    Site Public Contact, 808-531-8521

    Karen Rowan

    Recruiting

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-906-4199, Research@CARTI.com

    Jay W. Carlson

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Amelia M. Jernigan

    Recruiting

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

    Site Public Contact, 573-302-2768, clinicaltrials@lakeregional.com

    Jay W. Carlson

    Recruiting

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

    Site Public Contact, 720-874-1881, ResearchInstituteInquiries@CommonSpirit.org

    Shahzad Siddique

    Recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Vamsi K. Vasireddy

    Recruiting

  • Aspirus Cancer Care-Wausau

    Wausau, Wisconsin, 54401

    Site Public Contact, 877-405-6866

    Andrew J. Huang

    Recruiting

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

    Site Public Contact, 715-422-7718

    Andrew J. Huang

    Recruiting

Other trials in United States

Puerto Rico4 sites, 4 recruiting

  • Puerto Rico Hematology Oncology Group

    Bayamón, 00961

    Site Public Contact, 787-780-2865

    Luis J. Santos Reyes

    Recruiting

  • Doctors Cancer Center

    Manati, 00674

    Site Public Contact, 787-621-4397

    Luis J. Santos Reyes

    Recruiting

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Luis J. Santos Reyes

    Recruiting

  • PROncology

    San Juan, 00927

    Site Public Contact, 787-919-7919, info@PRoncology.com

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

About this study

Official title: Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment (SYMON)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Counseling, Health Education, Interview, Medical Chart Review, Monitoring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CounselingOther

    Also called Counseling Intervention

    Receive TIPC

  • Health EducationBehavioural

    Receive handbook

  • InterviewOther

    Ancillary studies

  • Medical Chart ReviewOther

    Also called Chart Review

    Ancillary studies

  • MonitoringOther

    Also called monitor

    Receive IVR symptom monitoring

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06279013
Study groupRoleWhat they receive
Arm I (IVR monitoring)Active comparatorPatients 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.
Receives: Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration
Arm II (ATSM, TIPC)ExperimentalPatients 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.
Receives: Other: Counseling; Behavioral: Health Education; Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom severity/toxicity index

    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.

    Measured: Up to 12 weeks from the start of therapy (trial interventions)

Secondary outcomes (1)

  1. Unscheduled health services

    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.

    Measured: Up to 17 weeks from the start of therapy (trial interventions)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start14 Oct 2024
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
486 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06279013
Sponsor's protocol ID
NRG-CC012CD
Other IDs
NCI-2023-10831, NRG-CC012CD, NRG-CC012CD, NRG-CC012CD, R01CA279472, UG1CA189867
Acronym
SYMON
Status last verified
Oct 2026
First submitted
1 Feb 2024
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Counseling, Health Education and Interview in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by NRG Oncology at 34 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom severity/toxicity index (time frame: Up to 12 weeks from the start of therapy (trial interventions)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06279013.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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