Metastatic CancerEPOST MBCNCT03983577
Efficacy of Point Of Service Testing in MBC
A study testing Point of service delivery model in people with Metastatic Cancer and Breast Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Breast Cancer
- What is being tested?
- Point of service delivery model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to Aug 2025
- 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
Who may be able to join
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
- Able to speak and read in the English language.
- Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
- Participants must be enrolled in the parent registry study.
Who cannot join
- Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
- Psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
Clinical Trials Nurse Navigator, 913-945-7552, ctnursenav@kumc.edu
About this study
Official title: Efficacy of Point Of Service Testing in Metastatic Breast Cancer
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.
- Conditions
- Metastatic Cancer, Breast Cancer
- Being tested
- Point of service delivery model
- Keywords
- genetic counseling
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of service delivery modelOther
Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.
| Study group | Role | What they receive |
|---|---|---|
| Point of service delivery model | Experimental | After the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model. Receives: Other: Point of service delivery model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.
Measured: 24 months
Secondary outcomes (3)
Overall participant satisfaction
Patient satisfaction will be assessed with an adapted Genetic Counseling Satisfaction Scale (aGCSS). Each item is scored from 1- 5, with 1 being strongly disagree and 5 being agree strongly. The scores are added then divided by 5 to give a mean score.
Measured: 24 months
Clinical decisional conflict score
Decisional conflict will be assessed using the Decisional Conflict Scale (Sure Test Version). The 4 items are summed. Scores range from 0 (extremely high decisional conflict) to 4 (no decisional conflict). A score of less than or equal to 3 indicates decisional conflict.
Measured: 24 months
Overall participant anxiety
Participant anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS-Anxiety scale). Each item is scored between 0- 3 with a total score between 0- 21 possible. Scores of 0-7 indicates normal; scores of 8-10 indicates borderline abnormal; scores of 11-21 indicates abnormal.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start11 Jun 2019
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Nye, MD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983577
- Sponsor's protocol ID
- ePOST
- Acronym
- EPOST MBC
- Status last verified
- Sep 2023
- First submitted
- 7 Jun 2019
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Point Of Service Testing in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03983577
- Acronym / sponsor ID
- EPOST MBC / ePOST
- Conditions
- Metastatic Cancer, Breast Cancer
- Keywords
- genetic counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Jun 2019 (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.
This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point of service delivery model | Experimental | Other: Point of service delivery modelAfter the informed consent is signed, the participant will watch a standardized video on the principles of genetic testing. At the end of the video, the provider will return to answer any remaining questions. The participant will receive pre- and post- surveys for evaluation of the delivery model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
- Able to speak and read in the English language.
- Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
- Participants must be enrolled in the parent registry study.
Key exclusion criteria (2 listed)
- Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
- Psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Point of service delivery modelParticipants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey. | Other | Point of service delivery model |
Primary outcome
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.
Time frame: 24 months
Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.
3 secondary outcomes
Overall participant satisfaction
Time frame: 24 months
Clinical decisional conflict score
Time frame: 24 months
Overall participant anxiety
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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.
Lauren Nye, MD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of service delivery model in people with Metastatic Cancer and Breast Cancer, run by University of Kansas Medical Center 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CT Nurse Navigator (913-945-7552, ctnursenav@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention. (time frame: 24 months). 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 25 Sep 2023.