Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults With Multiple Myeloma

NCT03068637 | Completed

• 1 other identifier: G405
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching objective of this study is to evaluate the feasibility, usability, and acceptability of an abbreviated, tablet-based geriatric assessment in a population of older adults with multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Feasibility, usability, and acceptability of a tablet-based modified geriatric assessment using online questionnaires.

  This study will evaluate the feasibility, usability, and acceptability of a tablet-based modified geriatric assessment completed by patients and presented to clinicians at a treatment decision-making visit for older adults with multiple myeloma. Data from multiple qualitative online questionnaires will be aggregated together to arrive at one reported value, utility of a tablet-based modified geriatric assessment.

  Years 1-2

• Physician use and perceived utility of the modified geriatric assessment

  This still will examine the physician use and perceived utility of the modified geriatric assessment including the use and utility of the mCGA to facilitate treatment decision-making.

  Years 1-2

Secondary Outcomes (4)

• Description of treatment decision making patterns chosen by hematologists managing older patients with multiple myeloma

  Years 1-2

• Description of rates of CTCAE Grade 3-5 toxicities in older adults with MM who receive treatment following a treatment decision making visit at which an mCGA is completed

  Years 1-2

• Description of the relationship between the mCGA and toxicity in older adults with MM over 3 months of chemotherapy

  Years 1-2

• Description of the relationship between the mCGA and dose modification and/or treatment discontinuation in older adults with MM over 3 months of chemotherapy.

  Years 1-2

Study Arms (1)

Care planning platform usage

EXPERIMENTAL

This intervention will focus on the use of the Carevive care planning software for multiple myeloma patients age 65 and older who are at a treatment decision-making timepoint.

Behavioral: Carevive CPS

Interventions

Carevive CPS BEHAVIORAL

This intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers.

Care planning platform usage

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Diagnosis of multiple myeloma
• Newly diagnoses or needing a new line of therapy and have not yet made a treatment decision
• Must be able to understand English

You may not qualify if:

• Any patient who cannot understand written or spoken English
• Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C, and D)

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

Study Sites (2)

City of Hope

Duarte, California, United States

Location

University of Rochester Medical Center

Rochester, New York, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: August 23, 2016
• Primary Completion: November 8, 2017
• Study Completion: April 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)