NRG-CC012CD

Open to Accrual

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Protocol Information

Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants

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

Principal Investigator

Alla Sikorskii, PhD

Status

Open to Accrual

Date Opened To Accrual

May 20, 2024


Disease Site

Cancer Care Delivery Research [CD] Other

Phase

Other

Developmental Therapeutics

No

Primary Objective

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 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).

Patient Population

Participants who have started an oral anti-cancer treatment other than hormonal therapy within the past 4 weeks.

 

Additional Information About NRG-CC012CD

This study is also looking to enroll practices and personnel.

Practice Eligibility: Practices (defined as a single NCORP affiliate or sub-affiliate; or NCORP affiliate and/or sub-affiliates that share the same physicians and/or staff but are in different locations) will be randomized to the adaptive ATSM+TIPC intervention or active control once all eligibility criteria specified below have been met. After approval of the letter of intent to participate in NRG-CC012CD a practice will have 90 days to complete protocol training.

Recruitment: 
Practice personnel = 48
Number of Practices = 12

Target Accrual

516

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.