Comparing different telephone methods for managing symptoms during cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of three different telephone-based interventions for managing symptoms and psychological distress in patients undergoing oral anti-cancer treatment. The interventions include Automated Telephone System Management (ATSM), Telephone Interpersonal Counseling (TIPC), and an active control group. The primary objective is to assess the impact of these interventions on a summary toxicity index of common symptoms, including anxiety and depression, over a 17-week period. Additionally, the study aims to evaluate the feasibility and acceptability of these interventions in community oncology practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.

Where it's running

• Cancer Center at Saint Joseph's
  Phoenix, Arizona, United States Recruiting
• CARTI Cancer Center
  Little Rock, Arkansas, United States Recruiting
• Phoebe Putney Memorial Hospital
  Albany, Georgia, United States Recruiting
• Augusta Oncology Associates PC-D'Antignac
  Augusta, Georgia, United States Recruiting
• Augusta University Medical Center
  Augusta, Georgia, United States Recruiting
• Queen's Cancer Cenrer - POB I
  Honolulu, Hawaii, United States Recruiting

Study contacts

• Principal investigator: Alla Sikorskii — NRG Oncology

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.