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

Study acronym: SYMON
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Feb 1, 2027 → Jun 1, 2028
Enrollment reduced 19% 600 → 486 participants
See other at-risk trials from NRG Oncology

Record History

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  1. Notable Primary completion pushed from Feb 1, 2027 to Jun 1, 2028 Show 6 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Enrollment reduced: 600 → 486 participants
    • Study completion pushed from May 1, 2032 to Jun 1, 2033
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study sites revised (34)
  2. Minor Study completion pushed from May 1, 2028 to May 1, 2032v16
  3. Minor Site details revised at 3 of 34 sitesv15
  4. 2 versions Re-verified since Feb 10, 2026, no change to tracked fieldsv13-v14
  5. Minor Study sites: 27 to 34
    • Secondary endpoints: details revised at 1 of 1 entry
    v12
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  1. Minor Study completion date: Apr 1, 2027 to May 1, 2028v11
  2. Minor Enrollment target: 564 to 600v10 Show 4 more changesShow less
    • Study sites: 26 to 27
    • Study completion date: May 1, 2028 to Apr 1, 2027
    • Eligibility criteria shortened, about 7 words
    • Study description expanded, about 39 words
  3. Notable Primary completion date: May 1, 2028 to Feb 1, 2027v9
  4. Notable Primary and study completion dates pushed to May 1, 2028v8
  5. Notable Start date: May 20, 2024 to Oct 14, 2024v7
  6. Minor Enrollment target: 516 to 564v6 Show 7 more changesShow less
    • Study completion date: May 1, 2028 to Apr 1, 2027
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoint revised
    • Primary endpoint revised
    • Study description shortened, about 22 words
    • Site contacts updated at 1 of 26 sites
    • Collaborators shortened, about 4 words
  7. Minor Study sites: 25 to 26v5
  8. Minor Study sites: 10 to 25v4
  9. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of Jun 16, 2024 to May 20, 2024
    v3
  10. Minor Primary endpoint revisedv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
67 trials monitored
See 5 trials at risk
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.
Trial Details
NCT Number NCT06279013
Lead Sponsor NRG Oncology
Conditions
(from sponsor)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Enrollment 486 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov