Breast CancerNCT04232319
Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
A study testing Sleep Hygiene Training in people with Breast Cancer and Sleep Hygiene, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Sleep Hygiene
- What is being tested?
- Sleep Hygiene Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to Jul 2020
- 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
- diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy,
- at least 18 years of age,
- women
- score > 5 on the Pittsburgh Sleep Quality Index
- Participant has a smartphone that operates on the Android or Apple platform
- Participant is able to use the Ecological Momentary Assessment application in the morning
- functional English fluency and literacy
Who cannot join
- self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment.
- Currently taking a pharmacological sleep aide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.
- Conditions
- Breast Cancer, Sleep Hygiene
- Being tested
- Sleep Hygiene Training
- Keywords
- Breast cancer, sleep, intervention, Sleep, Intervention, Self-management
- Medical subject headings
- Breast Neoplasms, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene TrainingBehavioural
The intervention will last approximately 45 minutes, and will be provided once/week for 3 weeks. The intervention is delivered "live" using web-cameras (e.g., Microsoft Zoom).
Registered and licensed occupational therapists will deliver the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge regarding sleep hygiene strategies and examples on how to apply these strategies to improve sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Training | Experimental | The intervention will be delivered online by an occupational therapist. The intervention consists of 3 weekly sessions; each session will be 30-45 minutes long. The focus of the intervention is to teach breast cancer survivors sleep hygiene strategies to improve their sleep. Receives: Behavioral: Sleep Hygiene Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Measures the quality of sleep
Measured: Baseline to 7 weeks
Secondary outcomes (4)
Change in Ecological Momentary Assessment of Sleep Quality
Ecological Momentary Assessments via Smartphone App
Measured: Baseline to 7 weeks
Change in Actigraphy-based measure of Sleep
Actigraphy-based measure of Sleep
Measured: Baseline to 7 weeks
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)
Measure individual's knowledge of Sleep Hygiene Strategies
Measured: Baseline to 7 weeks
Change in Ecological Momentary Assessment of Sleep Quantity
Ecological Momentary Assessments via Smartphone App
Measured: Baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start15 Jan 2020
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Due to COVID this study was never started.
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.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketki D Raina, PhD, OTR/L, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232319
- Sponsor's protocol ID
- UT BCS Sleep Study
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2019
- Last updated
- 26 Nov 2024
- 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04232319
- Acronym / sponsor ID
- UT BCS Sleep Study
- Conditions
- Breast Cancer, Sleep Hygiene
- Keywords
- Breast cancer, sleep, intervention, Sleep, Intervention, Self-management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID this study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Jan 2020 (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.
The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Training | Experimental | Behavioral: Sleep Hygiene TrainingThe intervention will be delivered online by an occupational therapist. The intervention consists of 3 weekly sessions; each session will be 30-45 minutes long. The focus of the intervention is to teach breast cancer survivors sleep hygiene strategies to improve their sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy,
- at least 18 years of age,
- women
- score > 5 on the Pittsburgh Sleep Quality Index
- Participant has a smartphone that operates on the Android or Apple platform
Key exclusion criteria (2 listed)
- self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment.
- Currently taking a pharmacological sleep aide
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 |
|---|---|---|
| Sleep Hygiene TrainingThe intervention will last approximately 45 minutes, and will be provided once/week for 3 weeks. The intervention is delivered "live" using web-cameras (e.g., Microsoft Zoom). Registered and licensed occupational therapists will deliver the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge regarding sleep hygiene strategies and examples on how to apply these strategies to improve sleep quality. | Behavioural | Sleep Hygiene Training |
Primary outcome
Change in Sleep Quality (Pittsburgh Sleep Quality Index)
Time frame: Baseline to 7 weeks
Measures the quality of sleep
4 secondary outcomes
Change in Ecological Momentary Assessment of Sleep Quality
Time frame: Baseline to 7 weeks
Change in Actigraphy-based measure of Sleep
Time frame: Baseline to 7 weeks
Change in knowledge of Sleep Hygiene Strategies (Sleep Hygiene Index)
Time frame: Baseline to 7 weeks
Change in Ecological Momentary Assessment of Sleep Quantity
Time frame: Baseline to 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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.
Ketki D Raina, PhD, OTR/L principal investigator
University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Training in people with Breast Cancer and Sleep Hygiene, run by University of Toledo Health Science Campus at 1 site 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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Sleep Quality (Pittsburgh Sleep Quality Index) (time frame: Baseline to 7 weeks). 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 26 Nov 2024.