Providing Cancer Care Closer to Home for Patients With Multiple Myeloma

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05971056
Collaborator
(none)
100
1
2
19
5.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Care transition
  • Other: No care transition
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

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.

Other: Care transition
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.

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of eligible participants who successfully transfer to the provider at a satellite location [At time of transfer decision (day 1)]

Secondary Outcome Measures

  1. Types of candidacy that providers use for transfer of care to satellite sites [At time of transfer decision (day 1)]

    Qualitative data collection

  2. Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire [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.

  3. Satisfaction of with participant-provider interactions as measured by the Questionnaire on the Quality of Physician-Patient Interaction [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.

  4. Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05971056
Other Study ID Numbers:
  • 202306162
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023