Multiple MyelomaNCT05971056
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
A study testing Care transition and No care transition in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Care transition and No care transition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- Care transition, No care transition
- Keywords
- access to care, travel burden, financial toxicity, patient satisfaction
- Medical subject headings
- Multiple Myeloma, Financial Stress, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care transitionOther
Cancer care is transitioned to a satellite site.
No care transitionOther
Cancer care is not transitioned to a satellite site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No care transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible participants who successfully transfer to the provider at a satellite location
Measured: At time of transfer decision (day 1)
Secondary outcomes (5)
Types of candidacy that providers use for transfer of care to satellite sites
Qualitative data collection
Measured: At time of transfer decision (day 1)
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.
Measured: 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
- 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.
Measured: Through completion of follow-up (estimated to be 6 months)
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.
Measured: 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.
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.
Measured: Through completion of follow-up (estimated to be 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start8 Sep 2023
- Primary completion22 Mar 2024
- Study completion22 Mar 2024
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Fiala, Ph.D., MSW, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971056
- Sponsor's protocol ID
- 202306162
- Status last verified
- Oct 2024
- First submitted
- 20 Jul 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural Experiment of Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05971056
- Acronym / sponsor ID
- 202306162
- Conditions
- Multiple Myeloma
- Keywords
- access to care, travel burden, financial toxicity, patient satisfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care transition | Experimental | Other: Care transition-At baseline, the participant and the provider will make a decision on if the participant will transfer care to a satellite location. |
| No care transition | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care transitionCancer care is transitioned to a satellite site. | Other | Care transition |
| No care transitionCancer care is not transitioned to a satellite site. | Other | No care transition |
Primary outcome
Proportion of eligible participants who successfully transfer to the provider at a satellite location
Time frame: At time of transfer decision (day 1)
5 secondary outcomes
Types of candidacy that providers use for transfer of care to satellite sites
Time frame: 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)
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)
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)
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)
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fiala, Ph.D., MSW principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care transition and No care transition in people with Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible participants who successfully transfer to the provider at a satellite location (time frame: At time of transfer decision (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.