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Comprehensive Frailty Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033928
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ashley Rosko, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date December 18, 2013
First Posted Date January 13, 2014
Last Update Posted Date February 28, 2018
Study Start Date April 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2014)
Change in Comprehensive Frailty Assessment [ Time Frame: up to 14 months ]
Responses to the Comprehensive Frailty Assessment will be assessed before and after treatment and changes will be evaluated. In transplant patients, this will be measured one year post transplant and in the non-transplant arm, this will be assessed after the second cycle of treatment.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02033928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 9, 2014)
Time to progression [ Time Frame: date of enrollment to date of documented clinical progression up to two years post-enrollment ]
We will assess time to progression for multiple myeloma patients and the relationships of those outcomes to patients' functional, cognitive and psychosocial health.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 9, 2014)
Overall survival [ Time Frame: enrollment to date of death up to two years post-enrollment ]
We will assess overall survival and the relationship of those measures to patients' functional, cognitive and psychosocial health.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Comprehensive Frailty Assessment
Official Title Comprehensive Frailty Assessment
Brief Summary The purpose of this research study is to describe a patients' fitness before and after treatment (whether that treatment be chemotherapy or a transplant). Fitness is a way of measuring a patient's current quality of health. With surveys, questionnaires and blood tests, we hope to create a tool that will give a good picture of patients' ability to tolerate treatment. In the future, we hope to devise the best treatment for a patient based on their "fitness".
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients at The Ohio State University with a plamsa cell dyscrasia and/or any patient receiving a blood or marrow transplant at Ohio State will be considered for this study.
Condition
  • Myeloma, Multiple
  • Paraproteinemias
  • Hematologic Neoplasms
Intervention Not Provided
Study Groups/Cohorts
  • Arm I: Transplant patients
  • Arm II: Plasma cell dyscrasia patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 21, 2016)
111
Original Estimated Enrollment
 (submitted: January 9, 2014)
400
Actual Study Completion Date August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with a plasma cell dyscrasia AND/OR any patient receiving a stem cell transplant for a hematologic malignancy at The Ohio State University
  • at least 18 years of age

Exclusion Criteria:

- Any medical or psychiatric condition that would make it difficult for the patient to comply with study procedures.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02033928
Other Study ID Numbers OSU-13135
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ashley Rosko, Ohio State University Comprehensive Cancer Center
Study Sponsor Ohio State University Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Ashley Rosko, MD The Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date February 2018