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Mindfulness may ease insomnia for breast cancer patients in rural areas

NCT ID NCT06529120

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a mindfulness-based program (Nite2Day) for women with breast cancer who have trouble sleeping. Participants learn strategies to cope with insomnia, fatigue, stress, and pain during six remote sessions with a therapist. The goal is to see if the program is practical and helpful for women in rural areas with limited access to care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

15 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. stage 0-IV breast cancer diagnosis within past 12 months 2. self-report \>8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia 3. \>18 years old 4. life expectancy of \>12 months per medical chart or oncologist 5. Ability to speak and read English, and intact hearing and vision Exclusion Criteria: 1. reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam \<25; 2. serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy, severe or moderate untreated sleep apnea) indicated by self-report, medical chart, or oncologist/provider that would contraindicate safe participation; 3. engagement in behavioral insomnia (e.g., Cognitive-Behavioral Therapy for Insomnia) or symptom management (e.g., Pain Coping Skills Training) interventions within past 6 months

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Calvert Health System

    Prince Frederick, Maryland, 20678, United States

  • Duke Lifepoint Hospital Maria Parham Medical Center

    Henderson, North Carolina, 27536, United States

  • Scotland Health Care System

    Laurinburg, North Carolina, 28352, United States

  • UNC Health Johnston

    Smithfield, North Carolina, 27577, United States

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