Actively Recruiting
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
Eligibility Criteria
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.
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
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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