Comprehensive Frailty Assessment

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT02033928

Collaborator

(none)

111

Enrollment

Location

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Myeloma, Multiple Paraproteinemias Hematologic Neoplasms

Study Design

Study Type:

Observational

Actual Enrollment :

111 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Comprehensive Frailty Assessment

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Arm I: Transplant patients
Arm II: Plasma cell dyscrasia patients

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Overall survival [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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