Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
NCT ID: NCT06279013
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2024-10-14
2028-05-01
Brief Summary
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Detailed Description
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I. Test the effectiveness of Automated Telephone System Management (ATSM) + Telephone Interpersonal Counseling (TIPC) versus active control on patient-level outcome of the summary toxicity index of 24 Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms that include depressive, anxiety, and other symptoms commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect) and 13-17 (sustained effect).
SECONDARY OBJECTIVE:
I. Test the effectiveness of ATSM+TIPC versus active control on patient-level outcome of unscheduled health services over weeks 1-12 and 13-17.
EXPLORATORY OBJECTIVES:
I. Evaluate implementation outcomes at the practice personnel level (physicians, nurses, nurse practitioners, advanced practice providers, physician assistants, medical assistants, pharmacists, social workers, and other behavioral health professionals):
Ia. Feasibility of implementation of the automated telephone symptom monitoring and TIPC at the community oncology practice.
Ib. Perceptions of acceptability of the automated telephone symptom monitoring and TIPC for the community oncology practice.
Ic. Perceptions of appropriateness of the automated telephone symptom monitoring and TIPC for the community oncology practice.
II. Estimate delivery cost of the ATSM+TIPC and active control and cost savings for the ATSM+TIPC versus active control as a result of reduced unscheduled health services use.
III. Estimate the effect of the ATSM+TIPC versus active control on patient-reported financial burden.
IV. Estimate the differences in the effect of the ATSM+TIPC versus active control on the primary and secondary outcomes according to concurrent administration of oral agent with immune checkpoint inhibitor, other targeted infusion therapy, infusion chemotherapy, or radiation therapy.
OUTLINE: Practices are randomized to 1 of 2 arms.
ARM I: 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.
ARM II: 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.
After completion of study intervention, patients are followed up during weeks 13-17 and practice personnel are assessed at intake and 12 and 25 months later.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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.
Interview
Ancillary studies
Medical Chart Review
Ancillary studies
Monitoring
Receive IVR symptom monitoring
Questionnaire Administration
Ancillary studies
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.
Counseling
Receive TIPC
Health Education
Receive handbook
Interview
Ancillary studies
Medical Chart Review
Ancillary studies
Monitoring
Receive IVR symptom monitoring
Questionnaire Administration
Ancillary studies
Interventions
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Counseling
Receive TIPC
Health Education
Receive handbook
Interview
Ancillary studies
Medical Chart Review
Ancillary studies
Monitoring
Receive IVR symptom monitoring
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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Alla Sikorskii
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Augusta Oncology Associates PC-D'Antignac
Augusta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Lake Regional Hospital
Osage Beach, Missouri, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Aspirus Medford Hospital
Medford, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States
Puerto Rico Hematology Oncology Group
Bayamón, , Puerto Rico
Doctors Cancer Center
Manatí, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
PROncology
San Juan, , Puerto Rico
Countries
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Other Identifiers
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NCI-2023-10831
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-CC012CD
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC012CD
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC012CD
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC012CD
Identifier Type: -
Identifier Source: org_study_id
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