NCT05971056

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

July 20, 2023

Last Update Submit

October 1, 2024

Conditions

Keywords

access to caretravel burdenfinancial toxicitypatient satisfaction

Outcome Measures

Primary Outcomes (1)

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

    At time of transfer decision (day 1)

Secondary Outcomes (5)

  • Types of candidacy that providers use for transfer of care to satellite sites

    At time of transfer decision (day 1)

  • Treatment burden of participants as measured by the Modified Treatment Burden Questionnaire

    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

    Through completion of follow-up (estimated to be 6 months)

  • Financial toxicity of participants as measured by the Comprehensive Score for Financial Toxicity

    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.

    Through completion of follow-up (estimated to be 6 months)

Study Arms (2)

Care transition

EXPERIMENTAL

-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

No care transition

ACTIVE COMPARATOR

-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

Interventions

Cancer care is transitioned to a satellite site.

Care transition

Cancer care is not transitioned to a satellite site.

No care transition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaFinancial StressPatient Satisfaction

Interventions

Patient Transfer

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesStress, PsychologicalBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHospitalizationHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mark Fiala, Ph.D., MSW

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 2, 2023

Study Start

September 8, 2023

Primary Completion

March 22, 2024

Study Completion

March 22, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations