Supportive Care for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01758484
First received: December 27, 2012
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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 Intervention
Hematopoietic/Lymphoid Cancer
Other: palliative care
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Study participation rates defined as the proportion of patients who consent to enroll [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    Will mainly be descriptive.

  • Completion time for the supportive care consultation [ Time Frame: Up to 90 days post-treatment ] [ Designated as safety issue: No ]
    Will mainly be descriptive.

  • Level of comfort / distress attributed to individual parts of the consultation [ Time Frame: Up to 90 days post-treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 90 days post-treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Stephanie Lee Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01758484     History of Changes
Other Study ID Numbers: 2659.00, NCI-2012-03009, P30CA015704
Study First Received: December 27, 2012
Last Updated: September 2, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014