SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Successful enrollment of 30 patient-caregiver pairs
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants will be (1) patients with advanced hematologic malignancies receiving care at a participating clinic; (2) their caregivers; (3) participating clinicians.
- •Inclusion Criteria:
- •adults (≥ 21 years old)
- •Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma & AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
- •planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.
Exclusion Criteria
- •chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
- •unable to read and respond to questions in English
- •lacks decision-making capacity, as determined by the patient's oncologist
- •unable to complete baseline interview
- •Inclusion Criteria:
- •adults (≥ 21 years old)
- •family member or friend of an eligible patient
- •Exclusion criteria:
- •unable to read and respond to questions in English
- •unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)
- •Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
Arms & Interventions
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.
Intervention: care management by oncology nurses (Behavioral)
Outcomes
Primary Outcomes
Successful enrollment of 30 patient-caregiver pairs
Time Frame: Baseline to 3 months
Secondary Outcomes
- Outcome assessment rate(Baseline to 3 months)
- Missing data(Baseline to 3 months)
- Acceptability(3 months)
- Intervention fidelity(Baseline to 3 months)
- Consent-to-approach rate(Baseline to 3 months)
- Enrolled-to-consent rate(Baseline to 3 months)
- Intervention completion rate(Baseline to 3 months)
Investigators
Yael Schenker, MD, MAS
Assistant Professor Director, Palliative Care Research
University of Pittsburgh