Back to resultsSupportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant
Primary Purpose
Hematopoietic/Lymphoid Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
palliative care
questionnaire administration
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Hematopoietic/Lymphoid Cancer focused on measuring Hematopoietic cell transplantation, Supportive/palliative care
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- English as primary language
- Planned autologous or allogeneic hematopoietic cell transplantation
- Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse
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
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (palliative care support)
Arm Description
Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center.
Outcomes
Primary Outcome Measures
Study participation rates defined as the proportion of patients who consent to enroll
Will mainly be descriptive.
Completion time for the supportive care consultation
Will mainly be descriptive.
Level of comfort / distress attributed to individual parts of the consultation
Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item.
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
Will mainly be descriptive. 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01758484
First Posted
December 27, 2012
Last Updated
February 29, 2016
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01758484
Brief Title
Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant
Official Title
FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT 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 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.
Detailed Description
PRIMARY OBJECTIVES:
I. Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period.
II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team.
III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.
OUTLINE:
Patients undergo supportive care consultation before transplantation and at least once monthly while they remain at the transplant center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic/Lymphoid Cancer
Keywords
Hematopoietic cell transplantation, Supportive/palliative 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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (palliative care support)
Arm Type
Experimental
Arm Description
Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center.
Intervention Type
Other
Intervention Name(s)
palliative care
Intervention Description
Undergo supportive care intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Study participation rates defined as the proportion of patients who consent to enroll
Description
Will mainly be descriptive.
Time Frame
Up to 5 months
Title
Completion time for the supportive care consultation
Description
Will mainly be descriptive.
Time Frame
Up to 90 days post-treatment
Title
Level of comfort / distress attributed to individual parts of the consultation
Description
Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item.
Time Frame
Up to 90 days post-treatment
Title
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
Description
Will mainly be descriptive. 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
Up to 90 days post-treatment
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 autologous or allogeneic hematopoietic cell transplantation
Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse
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
Stephanie Lee
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant
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