NotablePrimary completion pushed from Feb 1, 2027 to Jun 1, 2028Show 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)
MinorStudy completion pushed from May 1, 2028 to May 1, 2032v16
MinorSite details revised at 3 of 34 sitesv15
2 versionsRe-verified since Feb 10, 2026, no change to tracked fieldsv13-v14
MinorStudy sites: 27 to 34
Secondary endpoints: details revised at 1 of 1 entry
v12
Show 10 earlier versionsHide 10 earlier versions
MinorStudy completion date: Apr 1, 2027 to May 1, 2028v11
MinorEnrollment target: 564 to 600v10Show 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
NotablePrimary completion date: May 1, 2028 to Feb 1, 2027v9
NotablePrimary and study completion dates pushed to May 1, 2028v8
NotableStart date: May 20, 2024 to Oct 14, 2024v7
MinorEnrollment target: 516 to 564v6Show 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
MinorStudy sites: 25 to 26v5
MinorStudy sites: 10 to 25v4
NotableTrial 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
MinorPrimary endpoint revisedv2
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.
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.