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

Primary Purpose

Malignancies, Hematologic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care Support
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignancies, Hematologic focused on measuring Allogeneic Stem Cell Transplant, Hematological Malignancies, Palliative Care, Supportive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Froedtert Hospital and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palliative Care Support

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Completion time for palliative care consultation
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.
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.

Full Information

First Posted
October 18, 2014
Last Updated
February 22, 2018
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT02321345
Brief Title
Pretransplant Evaluation by Supportive Care Team for Patients Undergoing HCT for Hematological Malignancies
Official Title
Feasibility of Implementing Pretransplant Evaluation by the Supportive Care Team for Patients Undergoing Hematopoietic Cell Transplantation for Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancies, Hematologic
Keywords
Allogeneic Stem Cell Transplant, Hematological Malignancies, Palliative Care, Supportive care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palliative Care Support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Palliative Care Support
Intervention Description
Palliative care meetings Quality of Life Assessments
Primary Outcome Measure Information:
Title
Study participation rates
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Completion time for palliative care consultation
Time Frame
up to 100 days
Title
Level of comfort / distress attributed to individual parts of the consultation
Description
The post-consultation scores measuring level of comfort or distress per topic in the palliative care consultation will be summarized per item.
Time Frame
Within 1-7 days after the initial consultation
Title
Completeness of follow-up data collection
Description
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.
Time Frame
1 year after the date last patient is enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Peltier, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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