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SYMON (NRG-CC012CD)

Managing symptoms and psychological distress during oral anti-cancer treatment (Sponsor NCI - R01 CA279472) 

Study Background

Oral agents are becoming an increasingly common modality for cancer treatment.

Patients receiving these treatments experience variable adherence and often high symptom burden, yet have limited contacted with their providers compared to patients receiving chemotherapy infusions. 

At least twelve NCORP community oncology sites, both rural and urban, will be recruited and cluster randomized. Community sites will participate for two years and will recruit a maximum of 45 patients receiving eligible oral agents. 

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As of August 2025, there are 15 approved recruitment sites. Congratulations to the following: 

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       Active Control 

  • CommonSpirit Health Research Institute/Cancer Center at Saint Joseph's

  • CROWN NCORP/Aspirus Regional Cancer Center

  • Georgia CaRes/Georgia Cancer Center

  • Ozarks NCORP AF/Lake Regional Hospital

  • Medical University of South Carolina NCORP/Hollings Cancer Center

  • Stroger Hospital of Cook County NCORP

  • New Mexico NCORP/UNM Comprehensive Cancer Center

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       ATSM+TIPC Intervention​

  • Upstate Carolina NCORP/AnMed Health Cancer Center

  • Ozarks NCORP/CARTI Cancer Center

  • Gulf South NCORP/LSU University Medical Center

  • Hawaii NCORP/UH Cancer Center/Queen's Cancer Center

  • Carle Cancer Center NCORP

  • NCORP of the Carolinas/Prisma Health Cancer Institute

  • Puerto Rico NCORP/Centro Comprensivo de Cancer de UPR
  • Closed​

       Closed

  • Ozarks NCORP/Central Care Cancer Center
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Study Design

CC012CD is a cluster-randomized trial where twelve or more eligible NCORP community sites will be recruited. At least six (6) practices will be randomized to the ATSM+TIPC intervention, and at least six (6) practices will be randomized to an active control (IVR only).

Practices will be asked to identify at minimum one (1) staff members who will be consented to participate in the study as clinic personnel. A maximum of 45 participants will be enrolled at each community site. For patients to be eligible to participate, they must be initiating treatment with an eligible oral agent.  

Intervention: ATSM+TIPC

Participants at these community sites will receive Interactive Voice Response (IVR) telephone symptom monitoring plus referral to self-management strategies provided via a printed handbook (ATSM). Any participants who report unresolved psychological distress in the first four (4) weeks will also receive Telephone Interpersonal Counselling (TIPC) for 8 weeks. Symptom reports from the IVR system will be sent to clinic personnel.

Active Control: IVR only

Participants at these community sites will receive Interactive Voice Response (IVR) telephone symptom monitoring only for 12 weeks. Symptom reports from the ATSM system will be sent to clinic personnel. 

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Community Site Work Flow

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Site Training Materials

Winter NRG 2024 Site Training 

Summer NRG 2024 Updated Site Training 

Monthly Study Updates

For updates prior to September 2025, please contact symon@miami.edu 

September 2025 Study Update

October 2025 Study Update

November 2025 Study Update

December 2025 Study Update

January 2026 Study Update

February 2026 Study Update

March 2026 Study Update

April 2026 Study Update

May 2026 Study Update

June 2026 Study Update

Other Resources

Sample Symptom Call
00:00 / 07:37

Study Chairs and Team

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Alla Sikorskii, PhD

Study Chair, PI

Michigan State University

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Tracy Crane, PhD, RDN

Study Chair, PI

University of Miami

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Terry Badger, PhD, RN

Study Chair, PI

University of Arizona

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Stephanie Pugh, PhD, Statistician, NRG Stats and Data Management

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Vamsi Vasireddy, DO, NCORP Community Chair, Carle Cancer Institute

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Melyssa Foust, MSN, RN,

Nursing Co-Chair, Upstate Carolina NCORP

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Jamillah Gross-Caldwell,

Study Coordinator - Michigan State University

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Grey Freylersythe,

Study Coordinator - University of Miami

Ready to Learn More?

Contact Us!

SYMON@miami.edu
(305) 243-9832

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