Comprehensive Frailty Assessment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02033928

Enrollment

111

Registered

2014-01-13

Start date

2014-04-30

Completion date

2017-08-31

Last updated

2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms, Myeloma, Multiple, Paraproteinemias

Keywords

Myeloma, MGUS (monoclonal gammopathy of undetermined significance), amyloidosis, stem cell transplant

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results