An interventional study of care management by oncology nurses in Advanced Cancer, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care
This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.
University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants will be (1) patients with advanced hematologic malignancies receiving care at a participating clinic; (2) their caregivers; (3) participating clinicians.
Patient:
Inclusion Criteria:
Exclusion criteria:
Caregiver
Inclusion Criteria:
Exclusion criteria:
Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
Behavioral: care management by oncology nurses
The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
Successful enrollment of 30 patient-caregiver pairs
Time frame: Baseline to 3 months
Consent-to-approach rate
Consent to approach rates will be tracked to assess feasibility
Time frame: Baseline to 3 months
Enrolled-to-consent rate
Enrolled-to-consent rates will be tracked to assess feasibility
Time frame: Baseline to 3 months
Intervention completion rate
Intervention completion rate among enrolled participants will be tracked to assess feasibility
Time frame: Baseline to 3 months
Intervention fidelity
Percent of intervention components completed according to protocol will be tracked to assess feasibility
Time frame: Baseline to 3 months
Outcome assessment rate
Outcome assessment rates among enrolled participants will be tracked to assess feasibility
Time frame: Baseline to 3 months
Missing data
Missing data rates will be tracked to assess feasibility
Time frame: Baseline to 3 months
Acceptability
We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include: 1. \> 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers. 2. \> 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future. 3. \> 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow. 4. \> 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.
Time frame: 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh