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

NCT06279013 | Recruiting DMC

• 4 other identifiers: NRG-CC012CDNCI-2023-10831R01CA279472UG1CA189867
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 34

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

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Symptom severity/toxicity index

  Toxicity index across 24 symptoms will be measured using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Linear mixed effects or generalized linear mixed effects models will be used.

  Up to 12 weeks from the start of therapy (trial interventions)

Secondary Outcomes (1)

• Unscheduled health services

  Up to 17 weeks from the start of therapy (trial interventions)

Other Outcomes (8)

• Practice personnel time to address weekly interactive voice response (IVR) symptom reports

  Up to 25 months

• Automated symptom monitoring and telephone interpersonal counseling (TIPC) delivery at the practice (Feasibility)

  Up to 25 months

• Practice personnel's actions on symptom reports

  Up to 25 months

Study Arms (2)

Arm I (IVR monitoring)

ACTIVE COMPARATOR

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.

Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration

Arm II (ATSM, TIPC)

EXPERIMENTAL

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.

Other: Counseling; Behavioral: Health Education; Other: Interview; Other: Medical Chart Review; Other: Monitoring; Other: Questionnaire Administration

Interventions

Counseling OTHER

Receive TIPC

Also known as: Counseling Intervention

Arm II (ATSM, TIPC)

Health Education BEHAVIORAL

Receive handbook

Arm II (ATSM, TIPC)

Interview OTHER

Ancillary studies

Arm I (IVR monitoring); Arm II (ATSM, TIPC)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Arm I (IVR monitoring); Arm II (ATSM, TIPC)

Monitoring OTHER

Receive IVR symptom monitoring

Also known as: monitor

Arm I (IVR monitoring); Arm II (ATSM, TIPC)

Questionnaire Administration OTHER

Ancillary studies

Arm I (IVR monitoring); Arm II (ATSM, TIPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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: Pregnancy at intake into the trial.

Sponsors & Collaborators

• NRG Oncology: lead

Study Sites (34)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

RECRUITING

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

RECRUITING

Phoebe Putney Memorial Hospital

Albany, Georgia, 31701, United States

RECRUITING

Augusta Oncology Associates PC-D'Antignac

Augusta, Georgia, 30901, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

RECRUITING

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

RECRUITING

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States

RECRUITING

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, 96706, United States

RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, 65065, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

RECRUITING

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409, United States

RECRUITING

Aspirus Medford Hospital

Medford, Wisconsin, 54451, United States

RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401, United States

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494, United States

RECRUITING

Puerto Rico Hematology Oncology Group

Bayamón, 00961, Puerto Rico

RECRUITING

Doctors Cancer Center

Manatí, 00674, Puerto Rico

RECRUITING

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

RECRUITING

PROncology

San Juan, 00927, Puerto Rico

RECRUITING

MeSH Terms

Interventions

Counseling; Interviews as Topic

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alla Sikorskii

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interviewers will be blinded to the study arm; IVR is automated.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 26, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (30); PR (4)