Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06279013

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

Led by NRG Oncology · Updated on 2026-05-07

600

Participants Needed

34

Research Sites

185 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Practices must be National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.
  • Practices must administer oral therapy to at least 40 eligible patients per year.
  • Practices must complete and submit the NRG-CC012CD Letter of Intent (LOI).
  • Practices must have or be willing to train a licensed social worker or behavioral health professional to deliver telephone interpersonal counseling (TIPC).
  • Practice personnel must be 18 years or older.
  • Practice personnel must plan to provide usual care for at least one enrolled patient during the study.
  • Practice personnel delivering TIPC must have or be eligible for behavioral counseling licensure if required.
  • Practice personnel must provide study-specific informed consent before joining.
  • Practices must enroll at least 8 patients in the first 6 months of participation.
  • Practices must complete monthly forms on actions taken on IVR symptom reports.
  • Practices must participate in monthly study calls throughout their participation.
  • Patients must be starting a new oral anti-cancer agent within 4 weeks after registration or have started one in the past 8 weeks, excluding sex hormone inhibitors.
  • Patients can use all concomitant medications and supportive care treatments.
  • Patients must be 18 years or older.
  • Patients must speak and understand English or Spanish.
  • Patients must have telephone access and ability to answer questions in English or Spanish.
  • Patients must provide study-specific informed consent and authorize release of personal health information.
Not Eligible

You will not qualify if you...

  • Practices with active telephone symptom management programs beyond symptom and oral agent adherence monitoring are excluded.
  • Patients receiving only sex hormone inhibitor treatment are excluded.
  • Patients enrolled in the intervention arm of another symptom management trial at intake are excluded.
  • Patients currently receiving regular behavioral counseling for psychological symptoms (at least two sessions in past 2 months) are excluded.
  • Patients who are pregnant at intake are excluded.

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Trial Site Locations

Total: 34 locations

1

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States, 85004

Actively Recruiting

2

CARTI Cancer Center

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Phoebe Putney Memorial Hospital

Albany, Georgia, United States, 31701

Actively Recruiting

4

Augusta Oncology Associates PC-D'Antignac

Augusta, Georgia, United States, 30901

Actively Recruiting

5

Augusta University Medical Center

Augusta, Georgia, United States, 30912

Actively Recruiting

6

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States, 96813

Actively Recruiting

7

Queen's Medical Center

Honolulu, Hawaii, United States, 96813

Actively Recruiting

8

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States, 96817

Actively Recruiting

9

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, United States, 96706

Actively Recruiting

10

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States, 60612

Actively Recruiting

11

Carle at The Riverfront

Danville, Illinois, United States, 61832

Actively Recruiting

12

Carle Physician Group-Effingham

Effingham, Illinois, United States, 62401

Actively Recruiting

13

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States, 61938

Actively Recruiting

14

Carle Cancer Center

Urbana, Illinois, United States, 61801

Actively Recruiting

15

Central Care Cancer Center - Garden City

Garden City, Kansas, United States, 67846

Actively Recruiting

16

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Actively Recruiting

17

Lake Regional Hospital

Osage Beach, Missouri, United States, 65065

Actively Recruiting

18

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

19

AnMed Health Cancer Center

Anderson, South Carolina, United States, 29621

Actively Recruiting

20

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

21

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States, 29605

Actively Recruiting

22

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States, 29605

Actively Recruiting

23

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States, 29605

Actively Recruiting

24

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States, 29615

Actively Recruiting

25

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States, 54409

Actively Recruiting

26

Aspirus Medford Hospital

Medford, Wisconsin, United States, 54451

Actively Recruiting

27

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States, 54501

Actively Recruiting

28

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States, 54481

Actively Recruiting

29

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States, 54401

Actively Recruiting

30

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States, 54494

Actively Recruiting

31

Puerto Rico Hematology Oncology Group

Bayamón, Puerto Rico, 00961

Actively Recruiting

32

Doctors Cancer Center

Manati, Puerto Rico, 00674

Actively Recruiting

33

Centro Comprensivo de Cancer de UPR

San Juan, Puerto Rico, 00927

Actively Recruiting

34

PROncology

San Juan, Puerto Rico, 00927

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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