Comprehensive Frailty Assessment

Hematologic Neoplasms Clinical Trial

Official title:

Comprehensive Frailty Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033928
• Other study ID #: OSU-13135
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: February 27, 2018
• Start date: April 2014
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Multiple Myeloma
• Myeloma, Multiple
• Neoplasms, Plasma Cell
• Paraproteinemias

Locations

Country	Name	City	State
United States	The Ohio State University Hospital East	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival	We will assess overall survival and the relationship of those measures to patients' functional, cognitive and psychosocial health.	enrollment to date of death up to two years post-enrollment
Primary	Change in Comprehensive Frailty Assessment	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.	up to 14 months
Secondary	Time to progression	We will assess time to progression for multiple myeloma patients and the relationships of those outcomes to patients' functional, cognitive and psychosocial health.	date of enrollment to date of documented clinical progression up to two years post-enrollment

External Links

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