Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Recruiting now · Not applicable

Conditions studied: Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

In brief

In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes.

Key facts

Study ID: NCT06279013
Run by: NRG Oncology
People needed: 600
Starts: 2024-10-14
Expected to finish: 2028-05-01
Last updated by the study team: 2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

PROncology — San Juan, Puerto Rico (enrolling)
CARTI Cancer Center — Little Rock, Arkansas, United States (enrolling)
Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico (enrolling)
Cancer Center at Saint Joseph's — Phoenix, Arizona, United States (enrolling)
Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States (enrolling)
Queen's Medical Center — Honolulu, Hawaii, United States (enrolling)
Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States (enrolling)
The Queen's Medical Center - West Oahu — ‘Ewa Beach, Hawaii, United States (enrolling)
John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States (enrolling)
Carle at The Riverfront — Danville, Illinois, United States (enrolling)
Carle Physician Group-Effingham — Effingham, Illinois, United States (enrolling)
Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States (enrolling)
Carle Cancer Center — Urbana, Illinois, United States (enrolling)
Central Care Cancer Center - Garden City — Garden City, Kansas, United States (enrolling)
University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)
Lake Regional Hospital — Osage Beach, Missouri, United States (enrolling)
University of New Mexico Cancer Center — Albuquerque, New Mexico, United States (enrolling)
AnMed Health Cancer Center — Anderson, South Carolina, United States (enrolling)
Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States (enrolling)
Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States (enrolling)
Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States (enrolling)
Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States (enrolling)
Langlade Hospital and Cancer Center — Antigo, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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