Advanced Cancer Clinical Trial
Official title:
SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
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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