NRG-CC012CD
Open to Accrual
Protocol Information
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.