Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
NRG Oncology
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.
Description
PRIMARY OBJECTIVE: I. Test the effectiveness of Automated Telephone System Management (ATSM) + Telephone Interpersonal Counseling (TIPC) versus active control on patient-level outcome of the summary toxicity index of 24 Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms that include depressive, anxiety, and other symptoms commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect) and 13-17 (sustained effect). SECONDARY OBJECTIVE: I. Test the effectiveness of ATSM+TIPC versus active control on patient-level outcome of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 l…
Interventions
- OtherCounseling
Receive TIPC
- BehavioralHealth Education
Receive handbook
- OtherInterview
Ancillary studies
- OtherMedical Chart Review
Ancillary studies
- OtherMonitoring
Receive IVR symptom monitoring
- OtherQuestionnaire Administration
Ancillary studies
Locations (34)
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- CARTI Cancer CenterLittle Rock, Arkansas
- Phoebe Putney Memorial HospitalAlbany, Georgia
- Augusta Oncology Associates PC-D'AntignacAugusta, Georgia
- Augusta University Medical CenterAugusta, Georgia
- Queen's Cancer Cenrer - POB IHonolulu, Hawaii