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Comprehensive Frailty Assessment

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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

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
Myeloma, Multiple Paraproteinemias Hematologic Neoplasms

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comprehensive Frailty Assessment
Study Start Date : April 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017


Group/Cohort
Arm I: Transplant patients
Arm II: Plasma cell dyscrasia patients



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033928


Locations
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United States, Ohio
The Ohio State University Hospital East
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Ashley Rosko, MD The Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Ashley Rosko, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02033928     History of Changes
Other Study ID Numbers: OSU-13135
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by Ashley Rosko, Ohio State University Comprehensive Cancer Center:
Myeloma
MGUS (monoclonal gammopathy of undetermined significance)
amyloidosis
stem cell transplant
Additional relevant MeSH terms:
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Hematologic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Paraproteinemias
Frailty
Pathologic Processes
Neoplasms by Site
Neoplasms
Hematologic Diseases
Blood Protein Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders