Pretransplant Evaluation by Supportive Care Team for Patients Undergoing HCT for Hematological Malignancies

Feasibility of Implementing Pretransplant Evaluation by the Supportive Care Team for Patients Undergoing Hematopoietic Cell Transplantation for Hematological Malignancies

This is a feasibility study of pre-transplant involvement of a palliative care provider in the setting of HCT. Although this is primarily a feasibility pilot, the investigators will explore how patients are affected by the palliative care meetings as well as test data collection mechanisms that would be used in a future randomized clinical trial.

The investigators hypothesis is that patients will be amenable to pre-transplant involvement of the palliative care team and might welcome the chance to discuss palliative care issues separate from the primary team. Palliative care providers also have special training and experience in conducting these interactions and expertise in supportive care practices. They will be available should a patient's condition become life- threatening. This study is therefore designed primarily to evaluate the level of comfort / distress of patients when a palliative care consultation and follow-up are integrated into their care.

Study Overview

• Status: Completed
• Conditions: Malignancies, Hematologic
• Intervention / Treatment: Other: Palliative Care Support

Detailed Description

After the patient provides written informed consent, they will be given a survey to collect baseline data. Because input may be solicited from the caregiver, consent will also be obtained from a caregiver. Participation is optional for the caregiver and a caregiver is not required for the participant to be in the study. If the caregiver does not consent to participate in the study, his/her input during meetings will not be documented in the research record. "Caregiver" may vary from patient to patient, but for the purposes of this study would be an individual who listens to the interview and responds to questions related to the patient's psychosocial history, goals and values. This information gathered from the caregiver supports the details of the consult but does not stand alone. The caregiver does not complete an evaluation of the interview but can reach out to study coordinators if the interview causes any distress.The first consultation will be scheduled with a palliative care provider, but will take place after the standard of care meeting with the social worker so that the palliative care clinician can read the social work note and not have to review the same information. Within one to seven days after the meeting with palliative care, patients will be asked to complete a 15 minute interview to provide feedback on the meeting. A brief questionnaire will also be administered to the palliative care provider who conducted the consultation, ideally immediately after the meeting. Patients will meet at least monthly with the palliative care provider while they remain at the transplant center. Patients will complete additional self-assessments at day 60+/- 7 days and 90+/- 7 days after their transplants. These surveys may be completed by mail if the patient has been discharged from the center. The medical records of participants will be reviewed to pilot items collecting data about references to the palliative care consultation and use of ACP within the first 100 days after HCT. Costs for participants will be retrieved from the inpatient and outpatient accounting systems for the first 100 days after HCT. Participants may decline to participate in any part of the study or discontinue participation at any time.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• English as primary language
• Planned allogeneic stem cell transplantation
• At least 18 years of age

Exclusion Criteria:

• Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team.
• First transplant of a planned tandem procedure (the second transplant is eligible)

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: Palliative Care Support; Palliative care meetings will address the following issues: 1) values and meaning of life 2) greatest hopes and fears 3) communication preferences 4) proxy readiness to make decisions, and patient preferences, if the patient were to become seriously ill, and 5) symptom management strategies.	Other: Palliative Care Support; Palliative care meetings Quality of Life Assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study participation rates	The proportion of patients who consent to enroll in the study will be computed based on the number approached. Reasons for non-participation will be summarized.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion time for palliative care consultation		up to 100 days
Level of comfort / distress attributed to individual parts of the consultation	The post-consultation scores measuring level of comfort or distress per topic in the palliative care consultation will be summarized per item.	Within 1-7 days after the initial consultation
Completeness of follow-up data collection	Completeness is defined by the proportion of instrument scores that can be calculated per given time point. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.	1 year after the date last patient is enrolled

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Wendy Peltier, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 18, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Palliative Care; Allogeneic Stem Cell Transplant; Supportive care; Hematological Malignancies
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 21301