Clinical trial NCT01758484: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic/Lymphoid Cancer
Keywords: Hematopoietic cell transplantation
Supportive/palliative care
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Study participation rates defined as the proportion of patients who consent to enroll
timeFrame: Up to 5 months
measure: Completion time for the supportive care consultation
timeFrame: Up to 90 days post-treatment
measure: Level of comfort / distress attributed to individual parts of the consultation
timeFrame: Up to 90 days post-treatment
measure: Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
timeFrame: Up to 90 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Stephanie Lee
role: PRINCIPAL_INVESTIGATOR
References: