Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

Not Applicable

Completed

• Conditions: Hematopoietic/Lymphoid Cancer

• Registration Number: NCT01758484
• Lead Sponsor: Fred Hutchinson Cancer 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.

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 Timeline

• Study First Submitted: 2012-12-27
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2013-01-01
• Study Start: 2013-04
• Primary Completion: 2014-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-29
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Study participation rates defined as the proportion of patients who consent to enroll	Up to 5 months	Will mainly be descriptive.
Completion time for the supportive care consultation	Up to 90 days post-treatment	Will mainly be descriptive.
Level of comfort / distress attributed to individual parts of the consultation	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.
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point	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.

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States