Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic/Lymphoid Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: palliative care

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

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 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)

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: 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: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: palliative care; Undergo supportive care intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study participation rates defined as the proportion of patients who consent to enroll	Will mainly be descriptive.	Up to 5 months
Completion time for the supportive care consultation	Will mainly be descriptive.	Up to 90 days post-treatment
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.	Up to 90 days post-treatment
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.	Up to 90 days post-treatment

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 27, 2012
• First Submitted That Met QC Criteria: December 27, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Hematopoietic cell transplantation; Supportive/palliative care
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2659.00; P30CA015704 (U.S. NIH Grant/Contract); NCI-2012-03009 (Registry Identifier: CTRP (Clinical Trial Reporting Program))