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Lifestyle Intervention for Uterine Fibroids

N/A
Recruiting
Led By Taraneh Shirazian, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have had a procedure or surgery performed to remove fibroids within the last 3 months and are now considered 'fibroid free.'
Participants ages 18-50, seeking care at the Center for Fibroid Care at NYU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 month, 12 month
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test a lifestyle program to see if it can help prevent fibroid growth.

Who is the study for?
This trial is for English-speaking women aged 18-50 who have recently had fibroid removal surgery at the Center for Fibroid Care at NYU and are now 'fibroid free.' They must have seen their primary care physician in the last three months. Women on certain medications, outside the post-surgery window, postmenopausal, unable to exercise, with dietary restrictions due to GI disorders, or who are pregnant cannot join.Check my eligibility
What is being tested?
The LIFE Study is testing a lifestyle intervention program focused on nutrition and exercise. It aims to see if this program can prevent fibroids from coming back by making it part of patients' daily lives. The study will check how well participants accept and stick to this program.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical reactions to new diet or exercise routines such as muscle soreness or digestive adjustments. However, no medical side effects like those from drugs are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery to remove fibroids within the last 3 months and am now considered 'fibroid free.'
Select...
I am between 18 and 50 years old and seeking care at the NYU Center for Fibroid Care.
Select...
I can speak, read, and write in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 month, 12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 month, 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of LIFE program as measured by Self report survey
Change in fibroid recurrence as measured by standard of care ultrasounds
Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention
Healthy patients aged 18-50 who have a uterus, identify as female and have come to the outpatient Center for Women's Health (CWH) for management of bleeding, pelvic pain and fibroids. They will be offered enrollment post-surgery or procedure and will be followed longitudinally for 12 months.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,351 Previous Clinical Trials
817,576 Total Patients Enrolled
Taraneh Shirazian, MDPrincipal InvestigatorNYU Langone Health

Media Library

LIFE program Clinical Trial Eligibility Overview. Trial Name: NCT05416424 — N/A
Uterine Fibroids Research Study Groups: Study group
Uterine Fibroids Clinical Trial 2023: LIFE program Highlights & Side Effects. Trial Name: NCT05416424 — N/A
LIFE program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05416424 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count of this investigation?

"Affirmative. According to data stored on clinicaltrials.gov, this study is still recruiting suitable participants; the trial was first made available on October 1st 2022 and was recently revised on September 1st 2022. 50 people are needed for enrolment across a single medical centre."

Answered by AI

Who is eligible to enroll in this clinical research study?

"To qualify for this research project, candidates must satisfy a range of conditions. Specifically, participants aged 18-50 with leiomyoma who are English speaking and literate, have been ‘fibroid free’ following surgery or treatment within the last 3 months, and visited their physician in that period too; all those attending NYU's Center For Fibroid Care are eligible."

Answered by AI

Are there age restrictions on participation in this therapeutic trial?

"This clinical trial is limited to individuals between 18 and 50 years of age. For younger and older patients, there are 1 and 21 trials respectively available for them."

Answered by AI

Is recruitment for this trial still ongoing?

"According to the clinicaltrials.gov repository, this trial is still in search for patients and was first posted on October 1st 2022 with an update occurring on September 1st of the same year."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

How responsive is this trial?

Most responsive sites:
  1. NYU Langone Health: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~15 spots leftby Dec 2024