Trial record 6 of 151 for:
Open Studies | "palliative care"
Palliative Care Support for Patients With Hematological Malignancies Undergoing Hematopoietic Cell Transplant
This study is currently recruiting participants.
Verified April 2013 by Fred Hutchinson Cancer Research Center
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01758484
First received: December 27, 2012
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
This pilot clinical trial studies palliative care support for patients with hematological malignancies undergoing hematopoietic cell transplant. Palliative care support may improve quality of life in this patient population.
| Condition | Intervention |
|---|---|
|
Hematopoietic/Lymphoid Cancer |
Other: palliative care consultation 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 Palliative Care Support 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 8 months ] [ Designated as safety issue: No ]Will mainly be descriptive.
- Completion time for the palliative care consultation [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]Will mainly be descriptive.
- Level of comfort / distress attributed to individual parts of the consultation [ Time Frame: Up to 8 months ] [ Designated as safety issue: No ]Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the palliative 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 8 months ] [ 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: | September 2013 (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 consultation
Undergo palliative care support
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 palliative 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 palliative care team.
III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.
OUTLINE:
Patients undergo palliative 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
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 | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Rebecca Clark 206-667-4160 | |
| Principal Investigator: Stephanie J. Lee | |
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: | April 8, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
Hematopoietic cell transplantation palliative care |
Additional relevant MeSH terms:
|
Hematologic Neoplasms Neoplasms by Site Neoplasms Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013