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

Study Background

Oral agents for chemotherapy are becoming an increasingly common modality for treatment

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

Twelve (12) NCORP community oncology sites, both rural and urban, will be recruited and cluster randomized. Community sites will participate for two years and will recruit 43 patients receiving oral chemotherapy. 

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Study Design

CC012CD is a cluster-randomized trial where twelve eligible NCORP community sites will be recruited. Six (6) practices will be randomized to the ATSM+TIPC intervention, and 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 total of 43 participants will be enrolled at each community site. For patients to be eligible to participate, they must be initiating treatment with an oral chemotherapy 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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Community Site Eligibility and Participation 

If you are interested in opening this trial at your NCORP community site, please contact us! 

Patient Recruitment

Eligibility and screening best practices and guidance coming soon! 

Study Chairs and Team

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Alla Sikorskii, PhD

Study Chair, PI

Michigan State University


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


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

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Melyssa Foust, MSN, RN,

Nursing Co-Chair, Upstate Carolina NCORP


Jamillah Gross-Caldwell,

Study Coordinator - Michigan State University


Grey Freylersythe,

Study Coordinator - University of Miami

Ready to Learn More?

Download the presentation from the NRG Summer 2023 Semiannual Meeting 

Watch the Cancer Care Cancer Delivery Committee Meeting presentation

(NRG-CC012CD update at 6:55)

Contact Us!

Grey Freylersythe 
(305) 243-9832

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