Clinical trial NCT02992171: Primary Palliative Care for Patients With Advanced Hematologic Malignancies
Official title: SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2016-12-14
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Participants will be (1) patients with advanced hematologic malignancies receiving care at a participating clinic; (2) their caregivers; (3) participating clinicians.

Patient:

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

Caregiver

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.

Primary outcomes:
measure: Successful enrollment of 30 patient-caregiver pairs
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Consent-to-approach rate
timeFrame: Baseline to 3 months
measure: Enrolled-to-consent rate
timeFrame: Baseline to 3 months
measure: Intervention completion rate
timeFrame: Baseline to 3 months
measure: Intervention fidelity
timeFrame: Baseline to 3 months
measure: Outcome assessment rate
timeFrame: Baseline to 3 months
measure: Missing data
timeFrame: Baseline to 3 months
measure: Acceptability
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yael Schenker, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: