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Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

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ClinicalTrials.gov Identifier: NCT01758484
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Hematopoietic/Lymphoid Cancer Other: palliative care Other: questionnaire administration Procedure: quality-of-life assessment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES
Study Start Date : April 2013
Actual Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Supportive care (palliative care support)
Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center.
Other: palliative care
Undergo supportive care intervention
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment



Primary Outcome Measures :
  1. Study participation rates defined as the proportion of patients who consent to enroll [ Time Frame: Up to 5 months ]
    Will mainly be descriptive.

  2. Completion time for the supportive care consultation [ Time Frame: Up to 90 days post-treatment ]
    Will mainly be descriptive.

  3. Level of comfort / distress attributed to individual parts of the consultation [ Time Frame: Up to 90 days post-treatment ]
    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.

  4. Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point [ Time Frame: Up to 90 days post-treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758484


Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephanie Lee Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01758484     History of Changes
Other Study ID Numbers: 2659.00
NCI-2012-03009 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016

Keywords provided by Fred Hutchinson Cancer Research Center:
Hematopoietic cell transplantation
Supportive/palliative care