- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05971056
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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)
|
|
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)
|
|
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)
|
|
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
Investigators
- Principal Investigator: Mark Fiala, Ph.D., MSW, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 202306162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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