Recruiting

IVR & ATSM & TIPC

Sponsor:

NRG Oncology

Code:

NCT06279013

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Counseling

Health Education

Interview

Medical Chart Review

Monitoring

Study Details

Brief summary:

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06279013

Start date

Oct 14, 2024

Status verified date

Jun, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Arm I (IVR monitoring)

Patients receive IVR symptom monitoring calls once a week for 12 weeks, and a summary symptom report is sent to their provider. Call duration is approximately 15 minutes.

experimental: Arm II (ATSM, TIPC)

Patients receive the Symptom Management and Survivorship handbook and receive IVR symptom monitoring calls for 12 weeks, with summary symptom reports sent to their provider. Call duration is approximately 20 minutes. Patients who report anxious, discouraged, or sad mood items on their monitoring calls for two consecutive weeks between weeks 1 and 4 also receive TIPC calls for up to 8 weeks. TIPC call duration is approximately 30 minutes.

Interventions

Counseling

Receive TIPC

Health Education

Receive handbook

Interview

Ancillary studies

Medical Chart Review

Ancillary studies

Monitoring

Receive IVR symptom monitoring

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Symptom severity/toxicity index [ Time Frame: Up to 12 weeks from the start of therapy (trial interventions) ]

Central Contacts and Locations

Locations

Cancer Center at Saint Joseph's

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Principal Investigator:

Shahzad Siddique

CARTI Cancer Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Jay W. Carlson

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

Anand P. Jillella

Queen's Cancer Cenrer - POB I

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-532-0315

Principal Investigator:

Karen Rowan

Queen's Medical Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Site Public Contact

808-545-8548

Principal Investigator:

Karen Rowan

Queen's Cancer Center - Kuakini

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Site Public Contact

808-531-8521

Principal Investigator:

Karen Rowan

The Queen's Medical Center - West Oahu

Recruiting

‘Ewa Beach, Hawaii, United States, 96706

Contacts

Site Public Contact

rohta@queens.org

Principal Investigator:

Karen Rowan

John H Stroger Jr Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-864-5204

Principal Investigator:

Deimante M. Tamkus

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Vamsi K. Vasireddy

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Vamsi K. Vasireddy

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Vamsi K. Vasireddy

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Vamsi K. Vasireddy

Central Care Cancer Center - Garden City

Recruiting

Garden City, Kansas, United States, 67846

Contacts

Principal Investigator:

Jay W. Carlson

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Amelia M. Jernigan

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Principal Investigator:

Jay W. Carlson

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Harmony Bowles

AnMed Health Cancer Center

Recruiting

Anderson, South Carolina, United States, 29621

Contacts

Principal Investigator:

John E. Doster

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Evan M. Graboyes

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Matthew F. Hudson

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Matthew F. Hudson

Prisma Health Greenville Memorial Hospital

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Matthew F. Hudson

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Principal Investigator:

Matthew F. Hudson

Langlade Hospital and Cancer Center

Recruiting

Antigo, Wisconsin, United States, 54409

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Medford Hospital

Recruiting

Medford, Wisconsin, United States, 54451

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - James Beck Cancer Center

Recruiting

Rhinelander, Wisconsin, United States, 54501

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54481

Contacts

Principal Investigator:

Andrew J. Huang

Aspirus Regional Cancer Center

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Site Public Contact

877-405-6866

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Wisconsin Rapids

Recruiting

Wisconsin Rapids, Wisconsin, United States, 54494

Contacts

Site Public Contact

715-422-7718

Principal Investigator:

Andrew J. Huang

More Information

Sponsor

NRG Oncology

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-06-25.