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

NCT02321345 | Completed

• 1 other identifier: 21301
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignancies, Hematologic

Keywords

Allogeneic Stem Cell Transplant; Hematological Malignancies; Palliative Care; Supportive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Completion time for palliative care consultation

  up to 100 days

• Level of comfort / distress attributed to individual parts of the consultation

  Within 1-7 days after the initial consultation

• Completeness of follow-up data collection

  1 year after the date last patient is enrolled

Study Arms (1)

Palliative Care Support

EXPERIMENTAL

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

Interventions

Palliative Care Support OTHER

Palliative care meetings Quality of Life Assessments

Palliative Care Support

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Wendy Peltier, MD

  Medical College of Wisconsin

  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: MD

Study Record Dates

• First Submitted: October 18, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)