Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

Hematopoietic/Lymphoid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758484
• Other study ID #: 2659.00
• Secondary ID: NCI-2012-03009P3
• Status: Completed
• Phase: N/A
• First received: December 27, 2012
• Last updated: February 29, 2016
• Start date: April 2013

Study information

• Verified date: February 2016
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer

Intervention

Other:
• palliative care
Undergo supportive care intervention
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study participation rates defined as the proportion of patients who consent to enroll	Will mainly be descriptive.	Up to 5 months	No
Primary	Completion time for the supportive care consultation	Will mainly be descriptive.	Up to 90 days post-treatment	No
Primary	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	No
Primary	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	No