Breast CancerNCT06529120
Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
A study testing Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills in people with Breast Cancer, run by Duke University at 4 sites in United States.
Trial summary
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Sep 2025to 2 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 0-IV breast cancer diagnosis within past 12 months
- self-report >8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
- >18 years old
- life expectancy of >12 months per medical chart or oncologist
- Ability to speak and read English, and intact hearing and vision
Who cannot join
- reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam <25;
- 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;
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke Lifepoint Hospital Maria Parham Medical Center
Henderson, North Carolina, 27536
Scotland Health Care System
Laurinburg, North Carolina, 28352
Calvert Health System
Prince Frederick, Maryland, 20678
UNC Health Johnston
Smithfield, North Carolina, 27577
About this study
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotely via conference (i.e., Zoom) or telephone. During these sessions, participants will learn mindfulness and cognitive-behavioral strategies to cope with nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Participants will be asked to complete three, brief (15-20 minute) surveys that will ask questions about their background, cancer diagnosis and treatments, cancer symptoms, and experience with the intervention. Participants will be compensated for completing all intervention sessions and surveys. Total study duration is about 12 weeks.
The greatest risk of this study is loss of confidentiality. Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Information learned from this study may also benefit other patients with cancer in the future.
- Conditions
- Breast Cancer
- Being tested
- Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping SkillsBehavioural
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
| Study group | Role | What they receive |
|---|---|---|
| Nite2Day | Experimental | Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day)
The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes. Receives: Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by study accrual
Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months
Measured: 6 months of study recruitment
Feasibility as measured by study attrition
Treatment feasibility will be shown by no more than 25% study attrition
Measured: 12 weeks (post-intervention)
Feasibility as measured by adherence
Adherence will be indicated by at least 75% of participants completing all study sessions and assessments
Measured: 16 weeks (1-month post-intervention)
Acceptability as measured by the 8-item Client Satisfaction Questionnaire (CSQ)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and summed to obtain an acceptability score ranging from 8 to 32, with higher scores indicating higher acceptability.
Measured: 12 weeks (post-intervention)
Change in insomnia symptoms
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Secondary outcomes (7)
Change in fatigue symptoms
Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in depressive symptoms
Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher worse depressive symptoms.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in anxiety symptoms
Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate worse anxiety symptoms.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain severity
Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain interference
Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in mindfulness
Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale - Revised (CAMS-R). Items are summed to achieve a total score ranging from 10 to 40. Higher scores indicate higher levels of mindfulness.
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in self-efficacy for symptom management
Self-efficacy for symptom management will be measured using the 8-item PROMIS Self-Efficacy for Managing Chronic Conditions (Managing Symptoms) measure. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher self-efficacy for managing chronic conditions (managing symptoms).
Measured: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start11 Sep 2025
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hannah M Fisher, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529120
- Sponsor's protocol ID
- Pro00116035
- Other IDs
- 5P30CA014236-50
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas
- ClinicalTrials.gov ID
- NCT06529120
- Acronym / sponsor ID
- Pro00116035
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotely via conference (i.e., Zoom) or telephone. During these sessions, participants will learn mindfulness and cognitive-behavioral strategies to cope with nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Participants will be asked to complete three, brief (15-20 minute) surveys that will ask questions about their background, cancer diagnosis and treatments, cancer symptoms, and experience with the intervention. Participants will be compensated for completing all intervention sessions and surveys. Total study duration is about 12 weeks.
The greatest risk of this study is loss of confidentiality. Benefits from participating might include learning skills to reduce nighttime sleep disturbances and daytime symptoms of fatigue, stress, and pain. Information learned from this study may also benefit other patients with cancer in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nite2Day | Experimental | Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping SkillsMindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (Nite2Day) The Nite2Day intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The Nite2Day intervention will consist of 6 weekly sessions that will between 45 and 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stage 0-IV breast cancer diagnosis within past 12 months
- self-report >8 on the Insomnia Severity Index, indicating at least mild symptoms of clinical insomnia
- >18 years old
- life expectancy of >12 months per medical chart or oncologist
- Ability to speak and read English, and intact hearing and vision
Key exclusion criteria (3 listed)
- reported or suspected cognitive impairment confirmed via Folstein Mini-Mental Status Exam <25;
- 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;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping SkillsMindfulness-based sleep strategies and cognitive-behavioral symptom coping skills. | Behavioural | Nite2Day |
Primary outcome
Feasibility as measured by study accrual
Time frame: 6 months of study recruitment
Treatment feasibility will be shown by meeting targeted study accrual (N = 15) in 6 months
Feasibility as measured by study attrition
Time frame: 12 weeks (post-intervention)
Treatment feasibility will be shown by no more than 25% study attrition
Feasibility as measured by adherence
Time frame: 16 weeks (1-month post-intervention)
Adherence will be indicated by at least 75% of participants completing all study sessions and assessments
Acceptability as measured by the 8-item Client Satisfaction Questionnaire (CSQ)
Time frame: 12 weeks (post-intervention)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and summed to obtain an acceptability score ranging from 8 to 32, with higher scores indicating higher acceptability.
Change in insomnia symptoms
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.
7 secondary outcomes
Change in fatigue symptoms
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in depressive symptoms
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in anxiety symptoms
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain severity
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain interference
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in mindfulness
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in self-efficacy for symptom management
Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah M Fisher, PhD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills in people with Breast Cancer, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by study accrual (time frame: 6 months of study recruitment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.