NCT01353677

Brief Summary

This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

7 active sites

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

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2014

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

May 12, 2011

Last Update Submit

July 24, 2017

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic stem cell transplantationQOL

Study Arms (1)

HSCT recipients

1. Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. 2. Signed informed consent form from adult patient or parent/guardian of pediatric patient. 3. Patient must have a valid mailing address within the United States to receive QOL surveys. 4. Ability to speak and read English. 5. Patients with access to a telephone.

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pediatric and adult allogeneic HCT recipients

You may qualify if:

  • Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
  • Signed informed consent form from adult patient or parent/guardian of pediatric patient.
  • Patient must have a valid mailing address within the United States to receive QOL surveys.
  • Ability to speak and read English.
  • Patients with access to a telephone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Florida

Gainesville, Florida, 32610, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Study Officials

  • Douglas Rizzo, MD, MS

    CIBMTR/ Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

July 1, 2011

Primary Completion

October 30, 2014

Study Completion

October 30, 2014

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(7)