Primary Palliative Care for Patients With Advanced Hematologic Malignancies

NCT02992171 | Completed

• 2 other identifiers: PRO16100199130225-PEP-16-205-01-PCSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Successful enrollment of 30 patient-caregiver pairs

  Baseline to 3 months

Secondary Outcomes (7)

• Consent-to-approach rate

  Baseline to 3 months

• Enrolled-to-consent rate

  Baseline to 3 months

• Intervention completion rate

  Baseline to 3 months

• Intervention fidelity

  Baseline to 3 months

• Outcome assessment rate

  Baseline to 3 months

Study Arms (1)

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.

Behavioral: care management by oncology nurses

Interventions

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.

care management by oncology nurses

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• adults (≥ 21 years old)
• family member or friend of an eligible patient
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Study Officials

• Yael Schenker, MD, MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Director, Palliative Care Research

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 14, 2016
• Study Start: May 2, 2017
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)