Lutherville, MDNCT05780814Now EnrollingIRB Ready

Breast Cancer Clinical Trial in Lutherville, MD

Access cutting-edge breast cancer treatment through this clinical trial at a research site in Lutherville. Study-provided care at no cost to qualified participants.

Sponsored by Johns Hopkins University

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Expert Care in Lutherville

Access breast cancer specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related breast cancer treatment provided free

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Check if you qualify for this breast cancer clinical trial in Lutherville, MD

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Lutherville

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lutherville site if eligible
  4. 4Begin participation

About This Breast Cancer Study in Lutherville

The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

18 years of age or older
Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
Willing to lose 10% of body weight
Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growth factor receptor 2 therapy/targeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)
Completed all planned/elective surgeries \>4 weeks before enrollment
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder
Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time \> 30 minutes, \> 3 nights/week
Reports sleep problems present for ≥ 3 months
Insomnia Severity Index Score ≥ 9

Exclusion Criteria

Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use
Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted
Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea/hypopnea Index (AHI) \> 15
Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
History of unstable psychiatric disorder
Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of ≥ 20 on the Center for Epidemiologic Studies Depression (CES-D)
Lactating, pregnant or plan to become pregnant in next 14 months
Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and/or Structured Clinical Interview (SCID)
Daily smoker/nicotine user
Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lutherville?

Yes, this clinical trial (NCT05780814) has an active research site in Lutherville, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Breast Cancer Treatment Options in Lutherville, MD

If you're searching for breast cancer treatment options in Lutherville, MD, this clinical trial (NCT05780814) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lutherville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced breast cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all breast cancer clinical trials near you to find additional studies recruiting in your area.

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