Comprehensive Frailty Assessment

Completed

• Conditions: Myeloma, Multiple; Hematologic Neoplasms; Paraproteinemias

• Registration Number: NCT02033928
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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 available

Study Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Study Start: 2014-04
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Comprehensive Frailty Assessment	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.

Secondary Outcome Measures

Name	Time	Method
Time to progression	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.

Trial Locations

Locations (1)

The Ohio State University Hospital East; 🇺🇸 Columbus, Ohio, United States