Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971056
• Other study ID #: 202306162
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Mark Fiala, Ph.D. MSW
• Phone: 314-273-2783
• Email: mfiala[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Care transition
Cancer care is transitioned to a satellite site.
• No care transition
Cancer care is not transitioned to a satellite site.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible participants who successfully transfer to the provider at a satellite location		At time of transfer decision (day 1)
Secondary	Types of candidacy that providers use for transfer of care to satellite sites	Qualitative data collection	At time of transfer decision (day 1)
Secondary	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.	Through completion of follow-up (estimated to be 6 months)
Secondary	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.	Through completion of follow-up (estimated to be 6 months)
Secondary	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.	Through completion of follow-up (estimated to be 6 months)
Secondary	Participant rationales for opting to transfer to a satellite site or maintain care at their usual site.	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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine