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Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care transition
No care transition
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Myeloma focused on measuring access to care, travel burden, financial toxicity, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Care transition

No care transition

Arm Description

-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.

-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.

Outcomes

Primary Outcome Measures

Proportion of eligible participants who successfully transfer to the provider at a satellite location

Secondary Outcome Measures

Types of candidacy that providers use for transfer of care to satellite sites
Qualitative data collection
Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire
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.
Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction
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.
Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity
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.

Full Information

First Posted
July 20, 2023
Last Updated
September 11, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05971056
Brief Title
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
Official Title
A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
access to care, travel burden, financial toxicity, patient satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care transition
Arm Type
Experimental
Arm Description
-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
Arm Title
No care transition
Arm Type
Active Comparator
Arm Description
-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location.
Intervention Type
Other
Intervention Name(s)
Care transition
Intervention Description
Cancer care is transitioned to a satellite site.
Intervention Type
Other
Intervention Name(s)
No care transition
Intervention Description
Cancer care is not transitioned to a satellite site.
Primary Outcome Measure Information:
Title
Proportion of eligible participants who successfully transfer to the provider at a satellite location
Time Frame
At time of transfer decision (day 1)
Secondary Outcome Measure Information:
Title
Types of candidacy that providers use for transfer of care to satellite sites
Description
Qualitative data collection
Time Frame
At time of transfer decision (day 1)
Title
Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire
Description
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.
Time Frame
Through completion of follow-up (estimated to be 6 months)
Title
Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction
Description
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.
Time Frame
Through completion of follow-up (estimated to be 6 months)
Title
Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity
Description
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.
Time Frame
Through completion of follow-up (estimated to be 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Fiala, Ph.D. MSW
Phone
314-273-2783
Email
mfiala@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fiala, Ph.D., MSW
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Fiala, Ph.D., MSW
Phone
314-273-2783
Email
mfiala@wustl.edu
First Name & Middle Initial & Last Name & Degree
Mark Fiala, Ph.D., MSW

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

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