Primary Palliative Care for Patients With Advanced Hematologic Malignancies

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 Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: care management by oncology nurses

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful enrollment of 30 patient-caregiver pairs	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent-to-approach rate	Consent to approach rates will be tracked to assess feasibility	Baseline to 3 months
Enrolled-to-consent rate	Enrolled-to-consent rates will be tracked to assess feasibility	Baseline to 3 months
Intervention completion rate	Intervention completion rate among enrolled participants will be tracked to assess feasibility	Baseline to 3 months
Intervention fidelity	Percent of intervention components completed according to protocol will be tracked to assess feasibility	Baseline to 3 months
Outcome assessment rate	Outcome assessment rates among enrolled participants will be tracked to assess feasibility	Baseline to 3 months
Missing data	Missing data rates will be tracked to assess feasibility	Baseline to 3 months
Acceptability	We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include: > 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers.; > 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future.; > 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow.; > 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.	3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Yael Schenker, MD, MAS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PRO16100199; 130225-PEP-16-205-01-PCSM (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No