NCT02992171

Primary Palliative Care for Patients With Advanced Hematologic Malignancies

SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-02
• Primary completion: 2020-03-19
• Completion: 2020-03-19
• First posted: 2016-12-14
• Last updated: 2020-04-24

Locations

1 site across 1 country: United States