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NCT04829539RECRUITINGIRB Ready

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy

Sponsored by University of Rochester NCORP Research Base

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 400 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

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

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life.

Who Can Participate

Inclusion Criteria

Be at least 18 years of age
Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
Be currently receiving any cancer treatment (surgery alone is excluded)
Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
Be able to speak, understand and read English to participate in the study assessments and interventions

Exclusion Criteria

Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or in the past 30 days. Use of psychotropics and sleep medication are allowed

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

400 participants

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Gender

ALL

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Sponsor

University of Rochester NCORP Research Base

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Kingman

Arizona

Location available
View Kingman location page
RECRUITING

Fort Smith

Arkansas

Location available
View Fort Smith location page
RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

Lafayette

Colorado

Location available
View Lafayette location page
RECRUITING

Lone Tree

Colorado

Location available
View Lone Tree location page
RECRUITING

Millville

Delaware

Location available
View Millville location page
RECRUITING

Newark

Delaware

Location available
View Newark location page
RECRUITING

Newark

Delaware

Location available
View Newark location page
RECRUITING

Rehoboth Beach

Delaware

Location available
View Rehoboth Beach location page

๐Ÿ“ And 144 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Sleep Problems Treatment in Kingman?

Join others in Arizona exploring innovative treatment options through clinical research

Sleep Problems Treatment Options in Kingman, Arizona

If you're searching for Sleep Problems treatment in Kingman, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Kingman, Fort Smith, Oakland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Sleep Problems. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 400 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Sleep Problems?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Sleep Problems

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Sleep Problems Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04829539. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.