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Not yet recruitingNCT07932782Updated Nov 12, 2026

Patient-Centered Clinical Trial Navigation: Addressing Gender Disparity in Clinical Trial Participation

An interventional study of Navigation Intervention and Usual Care in Breast Cancer, sponsored by Medical College of Wisconsin. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Health services research

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Breast Neoplasms by Medical College of Wisconsin — 7 open to participants now, 11 under way, none of them phase 3. Breast Neoplasms · Medical College of Wisconsin.

Planned enrollment
9th of 17
45 · median 45
Started
2027
the only one that year
No phase
12 of 23
4 open now
Primary completion
2029-01
later than 10 of 10 live
Registered
23rd of 23
by date

Among the 23 studies in Breast Neoplasms by Medical College of Wisconsin, this one is the 9th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2027, is one of 12 with no phase, reaches primary completion later than 10 of the 10 other live ones, and was the 23rd registered.

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

7 of the 23 studies in Breast Neoplasms by Medical College of Wisconsin are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Breast Neoplasms by Medical College of Wisconsin, or all of them as a file.
02

Study summary

This is a two-arm, open-label, randomized interventional study involving women newly diagnosed with breast cancer.

Read the detailed description

This project seeks to address inequities in participation in clinical trials, which are defined as studies that are prospectively evaluating the effects of an intervention, among women through a structured patient navigation program that focuses on provided education about clinical trials.

03

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • patient navigator
  • gender disparities
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years.
  • Female patients who have a new breast cancer diagnosis with no prior treatment.
  • Proficient in the English Language.

Exclusion criteria

Exclusion Criteria:

  • Any prior cancer treatment.
  • A cancer recurrence or previously treated cancer.
  • Any prior participation in a clinical trial.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Navigation Intervention

    Only patients assigned to Arm 1 (Navigation) will be provided clinical trial education by the navigator ahead of MD consultation.

    Other: Navigation Intervention

  • Experimental
    Usual Care

    Patients will only have an MD consultation about clinical trials.

    Other: Usual Care

Interventions

  • OtherNavigation Intervention

    Women assigned to Arm 1 will receive tailored navigation services, including clinical trial education starting before their first MD consult and continuing throughout their treatment, which may include recruitment to a clinical trial.

  • OtherUsual Care

    Arm 2 will receive usual care, which includes MD consultation and execution of the resultant care plan.

06

What researchers measure

Primary outcomes

  1. Feasibility of conducting a future clinical trial

    This will be measured by 100% of recruitment goal within 12 months of enrollment opening date; 80% completion of A-ARTQ post clinical trial education; 70% completion of 6-month follow-up post initial MD consultation. The ARTQ is a validated questionnaire to better understand patient perceptions of participating in a randomized clinical trial. To ensure an appropriate literacy level, the survey being used for this study was adapted to improve readability, clarity and patient understanding (A-ARTQ).

    Time frame: 1 Year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 24 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartEst.
Jan 15, 2027
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932782
Responsible party
Adrienne Cobb, MD (Assistant Professor, Medical College of Wisconsin) — Principal investigator
First posted
Nov 12, 2026
Start date
Jan 15, 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office
Contact
cccto@mcw.edu
866-680-0505 ext. 8900
Adrienne Cobb, MD, MS
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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