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

NRG Oncology · NCT06279013

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
486
US sites recruiting
30
Study start
October 14, 2024
Record last updated
October 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Counseling; Health Education; Interview; Medical Chart Review; Monitoring; Questionnaire Administration

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Cancer Center at Saint Joseph's

    Phoenix, AZ 85004

    Site contact: Site Public Contact · 720-874-1881 · ResearchInstituteInquiries@CommonSpirit.org

  • CARTI Cancer Center

    Little Rock, AR 72205

    Site contact: Site Public Contact · 501-906-4199 · Research@CARTI.com

  • Phoebe Putney Memorial Hospital

    Albany, GA 31701

    Site contact: Site Public Contact · 229-312-0405 · ga_cares@augusta.edu

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, GA 30901

    Site contact: Site Public Contact · 706-821-2944

  • Augusta University Medical Center

    Augusta, GA 30912

    Site contact: Site Public Contact · 706-721-2388 · ga_cares@augusta.edu

  • Queen's Cancer Cenrer - POB I

    Honolulu, HI 96813

    Site contact: Site Public Contact · 808-532-0315

  • Queen's Medical Center

    Honolulu, HI 96813

    Site contact: Site Public Contact · 808-545-8548

  • Queen's Cancer Center - Kuakini

    Honolulu, HI 96817

    Site contact: Site Public Contact · 808-531-8521

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, HI 96706

    Site contact: Site Public Contact · rohta@queens.org

  • John H Stroger Jr Hospital of Cook County

    Chicago, IL 60612

    Site contact: Site Public Contact · 312-864-5204

  • Carle at The Riverfront

    Danville, IL 61832

    Site contact: Site Public Contact · 800-446-5532 · Research@Carle.com

  • Carle Physician Group-Effingham

    Effingham, IL 62401

    Site contact: Site Public Contact · 800-446-5532 · Research@carle.com

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, IL 61938

    Site contact: Site Public Contact · 800-446-5532 · Research@carle.com

  • Carle Cancer Center

    Urbana, IL 61801

    Site contact: Site Public Contact · 800-446-5532 · Research@carle.com

  • Central Care Cancer Center - Garden City

    Garden City, KS 67846

    Site contact: Site Public Contact · 913-948-5588 · aroland@kccop.org

  • University Medical Center New Orleans

    New Orleans, LA 70112

    Site contact: Site Public Contact · 504-210-3539 · emede1@lsuhsc.edu

  • Lake Regional Hospital

    Osage Beach, MO 65065

    Site contact: Site Public Contact · 573-302-2768 · clinicaltrials@lakeregional.com

  • University of New Mexico Cancer Center

    Albuquerque, NM 87106

    Site contact: Site Public Contact · 505-925-0348 · HSC-ClinicalTrialInfo@salud.unm.edu

  • AnMed Health Cancer Center

    Anderson, SC 29621

    Site contact: Site Public Contact · 864-512-4651 · rhonda.ballew@anmedhealth.org

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Site Public Contact · 843-792-9321 · hcc-clinical-trials@musc.edu

  • Prisma Health Cancer Institute - Butternut

    Greenville, SC 29605

    Site contact: Site Public Contact · 864-522-4317 · Kim.Williams3@prismahealth.org

  • Prisma Health Cancer Institute - Faris

    Greenville, SC 29605

    Site contact: Site Public Contact · 864-522-4317 · Kim.Williams3@prismahealth.org

  • Prisma Health Greenville Memorial Hospital

    Greenville, SC 29605

    Site contact: Site Public Contact · 864-522-4317 · Kim.Williams3@prismahealth.org

  • Prisma Health Cancer Institute - Eastside

    Greenville, SC 29615

    Site contact: Site Public Contact · 864-522-4317 · Kim.Williams3@prismahealth.org

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, WI 54409

    Site contact: Site Public Contact · 715-623-9869 · Juli.Alford@aspirus.org

  • Aspirus Medford Hospital

    Medford, WI 54451

    Site contact: Site Public Contact · 715-847-2353 · Beth.Knetter@aspirus.org

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, WI 54501

    Site contact: Site Public Contact · 715-847-2353 · Beth.Knetter@aspirus.org

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, WI 54481

    Site contact: Site Public Contact · 715-847-2353 · Beth.Knetter@aspirus.org

  • Aspirus Cancer Care-Wausau

    Wausau, WI 54401

    Site contact: Site Public Contact · 877-405-6866

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, WI 54494

    Site contact: Site Public Contact · 715-422-7718

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Comparing Telephone Symptom Monitoring Interventions for Managing… (NCT06279013) | Bored Studies