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| ID | Type | Description | Link |
|---|---|---|---|
| 130225-PEP-16-205-01-PCSM | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| care management by oncology nurses | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| care management by oncology nurses | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful enrollment of 30 patient-caregiver pairs | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Consent-to-approach rate | Consent to approach rates will be tracked to assess feasibility | Baseline to 3 months |
| Enrolled-to-consent rate | Enrolled-to-consent rates will be tracked to assess feasibility |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yael Schenker, MD, MAS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2018 | Oct 21, 2019 | ICF_000.pdf |
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| Baseline to 3 months |
| Intervention completion rate | Intervention completion rate among enrolled participants will be tracked to assess feasibility | Baseline to 3 months |
| Intervention fidelity | Percent of intervention components completed according to protocol will be tracked to assess feasibility | Baseline to 3 months |
| Outcome assessment rate | Outcome assessment rates among enrolled participants will be tracked to assess feasibility | Baseline to 3 months |
| Missing data | Missing data rates will be tracked to assess feasibility | 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:
| 3 months |