Primary Palliative Care for Patients With Advanced Hematologic Malignancies

Advanced Cancer Clinical Trial

Official title:

SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992171
• Other study ID #: PRO16100199
• Secondary ID: 130225-PEP-16-20
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: March 19, 2020

Study information

• Verified date: April 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful enrollment of 30 patient-caregiver pairs		Baseline to 3 months
Secondary	Consent-to-approach rate	Consent to approach rates will be tracked to assess feasibility	Baseline to 3 months
Secondary	Enrolled-to-consent rate	Enrolled-to-consent rates will be tracked to assess feasibility	Baseline to 3 months
Secondary	Intervention completion rate	Intervention completion rate among enrolled participants will be tracked to assess feasibility	Baseline to 3 months
Secondary	Intervention fidelity	Percent of intervention components completed according to protocol will be tracked to assess feasibility	Baseline to 3 months
Secondary	Outcome assessment rate	Outcome assessment rates among enrolled participants will be tracked to assess feasibility	Baseline to 3 months
Secondary	Missing data	Missing data rates will be tracked to assess feasibility	Baseline to 3 months
Secondary	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