RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment

Quick Facts

Study Start:2024-05-20
Study Completion:2028-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06279013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRACTICES: All institutions participating in the practice are National Cancer Institute Community Oncology Research Program (NCORP) affiliates or sub-affiliates.
  2. * PRACTICES: Administer oral therapy to at least 40 patients per year that meet protocol eligibility criteria.
  3. * PRACTICES: Completion and submission of the NRG-CC012CD Letter of Intent (LOI) (posted on the Cancer Trials Support Unit \[CTSU\] website).
  4. * 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 obtained by the study team.
  5. * PRACTICE PERSONNEL: Age ≥ 18 years.
  6. * PRACTICE PERSONNEL: Planned to be involved in usual care for at least one enrolled patient during patient's participation in the study.
  7. * 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.
  8. * PRACTICE PERSONNEL: The practice personnel must provide study-specific informed consent prior to study entry.
  9. * 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.
  10. * 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.
  11. * RETAIN PRACTICE PARTICIPATION: Participate in monthly study calls for the duration of practice's participation in the study.
  12. * 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 4 weeks.
  13. * PATIENTS: All concomitant medications and supportive care treatments are acceptable.
  14. * PATIENTS: Age ≥ 18 years.
  15. * PATIENTS: Able to speak and understand English or Spanish.
  16. * PATIENTS: Access to a telephone and ability to answer questions via telephone in English or Spanish.
  17. * PATIENTS: The patient must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information.
  1. * PRACTICES: Active telephone symptom management program at the practice that is beyond symptom and oral agent adherence monitoring.
  2. * PATIENTS: Current treatment with immune checkpoint inhibitor.
  3. * PATIENTS: Only receiving treatment with sex hormone inhibitors.
  4. * 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.
  5. * 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.

Contacts and Locations

Principal Investigator

Alla Sikorskii
PRINCIPAL_INVESTIGATOR
NRG Oncology

Study Locations (Sites)

Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846
United States
Lake Regional Hospital
Osage Beach, Missouri, 65065
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621
United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409
United States
Aspirus Medford Hospital
Medford, Wisconsin, 54451
United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501
United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481
United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401
United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494
United States

Collaborators and Investigators

Sponsor: NRG Oncology

  • Alla Sikorskii, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2028-05-01

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2028-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid System Neoplasm
  • Malignant Solid Neoplasm