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NCT06279013 · ClinicalTrials.gov registry record · NA
Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
A NA study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by NRG Oncology.
- Recruiting
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT06279013: Recruiting NA study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, sponsored by NRG Oncology.
NCT06279013 is a NA study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 600 participants, below the 1,137-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06279013, a NA study of Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Medical Chart Review
- OTHER Interview
- BEHAVIORAL Health Education
- OTHER Counseling
- OTHER Monitoring
Study Locations (20)
Illinois
- John H Stroger Jr Hospital of Cook County - Chicago
- Carle at The Riverfront - Danville
- Carle Physician Group-Effingham - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Carle Cancer Center - Urbana
Hawaii
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
- The Queen's Medical Center - West Oahu - ‘Ewa Beach
Georgia
- Phoebe Putney Memorial Hospital - Albany
- Augusta Oncology Associates PC-D'Antignac - Augusta
- Augusta University Medical Center - Augusta
South Carolina
- AnMed Health Cancer Center - Anderson
- Medical University of South Carolina - Charleston
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- CARTI Cancer Center - Little Rock
Kansas
- Central Care Cancer Center - Garden City - Garden City
Louisiana
- University Medical Center New Orleans - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2028-05-01 |
| Phase | NA |
What NCT06279013 shows while recruiting
NCT06279013 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,137-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Medical Chart Review is the first listed.
NCT06279013 names 20 study sites across 10 states, led by Illinois, Hawaii, Georgia.
Frequently Asked Questions
What is clinical trial NCT06279013 about?
NCT06279013 is a clinical study titled "Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment". 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 receivi...
What is the current status of trial NCT06279013?
This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2024-10-14. Estimated completion is 2028-05-01.
What conditions does trial NCT06279013 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm.
What interventions are being tested in trial NCT06279013?
The interventions under investigation include: Medical Chart Review (OTHER), Interview (OTHER), Health Education (BEHAVIORAL), Counseling (OTHER), Monitoring (OTHER).
Who is sponsoring clinical trial NCT06279013?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06279013 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Georgia, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06279013's enrollment target sits among peer trials
600 26th of 176 higher than 149 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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