NCT01758484

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

December 27, 2012

Last Update Submit

February 29, 2016

Conditions

Hematopoietic/Lymphoid Cancer

Keywords

Hematopoietic cell transplantationSupportive/palliative care

Outcome Measures

Primary Outcomes (4)

  • Study participation rates defined as the proportion of patients who consent to enroll

    Will mainly be descriptive.

    Up to 5 months

  • Completion time for the supportive care consultation

    Will mainly be descriptive.

    Up to 90 days post-treatment

  • 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

  • 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

Study Arms (1)

Supportive care (palliative care support)

EXPERIMENTAL

Patients undergo palliative care support before transplantation and at least once monthly while they remain at the transplant center.

Other: palliative careOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

palliative careOTHER

Undergo supportive care intervention

Supportive care (palliative care support)
questionnaire administrationOTHER

Ancillary studies

Supportive care (palliative care support)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (palliative care support)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephanie Lee

    Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2012

First Posted

January 1, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

US(1)