Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

October 1, 2024 updated by: Washington University School of Medicine

A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

There is very limited data on the utilization of National Cancer Institute Comprehensive Cancer Center (NCI-CCC) satellite sites in general. Of what is available, most is in regards to providing chemotherapy at facilities closer to patients' home. These "satellite chemotherapy infusion centers", typically community-based treatment locations at community hospitals/facilities, freestanding clinics, or mobile units, are reported to be well liked by patients who utilize their services and reduce their travel times and expenses. In these studies patients still remained in the care of their current provider and site and are required to travel to the site for clinical visits and other appointments. It is currently unknown if patients are willing to transfer their care to a different provider to alleviate travel burden. In addition, although increased travel burden has been lower quality of life in cross-sectional studies, no data exists suggesting that these reducing travel burden can improve these outcomes intra-patient, to the knowledge of the investigators.

The patient roles of the multiple myeloma clinical providers at the Siteman primary location have grown in recent years. The providers have determined a need to refer some patients to the satellite sites to relieve congestion at the site while also hopefully improving the clinical experience for those patients. This study is a natural experiment of this process.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility Criteria

  • At least 18 years old
  • Diagnosed with multiple myeloma
  • Receiving care from a provider within the Division of Oncology at the primary Siteman Cancer Center site
  • Resides within the catchment area of a Siteman Cancer Center satellite site
  • Able to read, speak, and understand English
  • Willing to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care transition
-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
Cancer care is transitioned to a satellite site.
Active Comparator: No care transition
-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
Cancer care is not transitioned to a satellite site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of eligible participants who successfully transfer to the provider at a satellite location
Time Frame: At time of transfer decision (day 1)
At time of transfer decision (day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of candidacy that providers use for transfer of care to satellite sites
Time Frame: At time of transfer decision (day 1)
Qualitative data collection
At time of transfer decision (day 1)
Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire
Time Frame: Through completion of follow-up (estimated to be 6 months)
  • Explore differences in participant experience between those that elect to transfer to a satellite site and those who decline to transfer.
  • The Modified Treatment Burden Questionnaire will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 3 questions with answers ranging from 0 (not a problem) to 10 (big problem). The higher the score the more treatment burden the participant experienced.
Through completion of follow-up (estimated to be 6 months)
Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction
Time Frame: Through completion of follow-up (estimated to be 6 months)
  • Explore differences in participant satisfaction between those that elect to transfer to a satellite site and those who decline to transfer.
  • The Questionnaire on the Quality of Physician-Patient Interaction will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 14 questions with answers ranging from 1 (do not agree) to 5 (I fully agree). The higher the score the higher the quality of the physician-patient interactions.
Through completion of follow-up (estimated to be 6 months)
Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity
Time Frame: Through completion of follow-up (estimated to be 6 months)
  • Explore differences in participant financial toxicity between those that elect to transfer to a satellite site and those who decline to transfer.
  • The Comprehensive Score for Financial Toxicity will be completed at baseline (time of transfer decision) and again approximately 6 months later. There are 11 questions with answers ranging from 0 (not at all) to 4 (very much). The higher the score the less financial toxicity the participant experienced.
Through completion of follow-up (estimated to be 6 months)
Participant rationales for opting to transfer to a satellite site or maintain care at their usual site.
Time Frame: Through completion of follow-up (estimated to be 6 months)
A sample of 20 patients, approximately 10 who decided to transfer and 10 who declined, will be surveyed in regards to the reason(s) for their decision as part of a sub-study. Patients who were not enrolled in the prospective portion of the study, either due to declining or not approached, will be allowed to enroll in the sub-study as long as they were offered the ability to transfer to a satellite site by their provider.
Through completion of follow-up (estimated to be 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mark Fiala, Ph.D., MSW, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

March 22, 2024

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 30, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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