Breast CancerNCT02613923
A Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
A study testing GO! To Sleep, Sleep information and Blood Draw in people with Breast Cancer and Sleep, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer. Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast… Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Sleep
- What is being tested?
- GO! To Sleep, Sleep information and Blood Draw
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2015to 23 Jul 2017
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women at high risk of breast cancer due to one or more of the following:
- Carry deleterious mutations in the BRCA1, BRCA2, PTEN, TP53, STK11, or CDH1 genes
- Previous diagnosis of lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH) or atypical lobular hyperplasia (ALH)
- Lifetime risk of 20% or greater as calculated by the National Cancer Institute (NCI) Breast Cancer Risk Assessment Tool or the Tyrer-Cuzick IBIS Risk Assessment Tool
- Ability to access the internet and watch videos online.
- Valid email address.
- Self-reported sleep duration of 6 hours per night or less
Who cannot join
- Previous diagnosis of cancer.
- Lack of ability to read and converse in English.
- Lack of ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.
Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.
The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.
Read the detailed description
Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.
Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.
Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.
- Conditions
- Breast Cancer, Sleep
- Being tested
- GO! To Sleep, Sleep information, Blood Draw, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI)
- Keywords
- Breast Cancer, GO! to sleep, sleep
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GO! To SleepBehavioural
Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
Sleep informationBehavioural
Participants will receive weekly emails on the health benefits of sleep for 6 weeks
Blood DrawProcedure or surgery
Also called biomarker measurement
blood sample measured for stress and sleep markers
Pittsburgh Sleep Quality Index (PSQI)Other
Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
Insomnia Severity Index (ISI)Other
SF-12 quality of life surveyOther
| Study group | Role | What they receive |
|---|---|---|
| GO! To Sleep | Experimental | Participants in the intervention group will be provided with a code and website address to participate in this program. This program includes reminder emails and is 6 weeks in duration. Participants will be given a blood draw to measure biomarkers. Receives: Behavioral: GO! To Sleep; Procedure: Blood Draw; Other: Pittsburgh Sleep Quality Index (PSQI); Other: Insomnia Severity Index (ISI); Other: SF-12 quality of life survey |
| informational control | Active comparator | Participants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers. Receives: Behavioral: Sleep information; Procedure: Blood Draw; Other: Pittsburgh Sleep Quality Index (PSQI); Other: Insomnia Severity Index (ISI); Other: SF-12 quality of life survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Measured: Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in Insomnia Severity Index (ISI) score between groups
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Measured: Change from baseline to post intervention, around 8 weeks after baseline
Difference in change in sleep duration between groups
Sleep duration will be obtained by self-report from responses to the PSQI
Measured: Change from baseline to post intervention, around 8 weeks after baseline
Secondary outcomes (5)
Difference in change of SF-12 score from baseline to post-intervention between groups
The effectiveness of changing health-related quality of life after the GO! To Sleep program will he measured with the self-reported survey SF-12
Measured: Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
This study will correlate the joint changes in biomarker level with the changes in sleep quality and sleep duration
Measured: Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Long term sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Measured: Change from baseline to 6 months post intervention
Difference in change in Insomnia Severity Index (ISI) score between groups
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Measured: Change from baseline to 6 months post intervention
Difference in change in sleep duration between groups
Sleep duration will be obtained by self-report from responses to the PSQI
Measured: Change from baseline to 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start4 Aug 2015
- Primary completion23 Mar 2017
- Study completion23 Jul 2017
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 Case Comprehensive Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl Thompson, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613923
- Sponsor's protocol ID
- CASE6114
- Status last verified
- May 2019
- First submitted
- 23 Nov 2015
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Sleep Intervention to Improve Outcomes Among Women at High Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT02613923
- Acronym / sponsor ID
- CASE6114
- Conditions
- Breast Cancer, Sleep
- Keywords
- Breast Cancer, GO! to sleep, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Jul 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- 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.
Participants are asked to participate in a research study of the effect of a sleep intervention on improving sleep habits and reducing their risk of breast cancer.
Participants are asked to participate in this research study because they have been identified as being at higher than average risk of developing breast cancer.
The purpose of this study is to compare women who get a sleep intervention to women who do not get a sleep intervention. This study team will compare these two groups of women to see if the sleep intervention improves their sleep and if it lowers markers of inflammation that have been associated with an increased risk of breast cancer.
Detailed description
Objective 1: To test the effectiveness of the GO! To Sleep program at improving the sleep duration and sleep quality in women at high risk of breast cancer.
Objective 2: To test the effectiveness of improvements in sleep quality and/or duration due to the GO! To Sleep program on biomarkers of inflammation in women at high risk of breast cancer.
Objective 3: To evaluate the effectiveness of improvements in health-related quality of life after the GO! To Sleep in women at high risk of breast cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GO! To Sleep | Experimental | Behavioral: GO! To Sleep, Procedure: Blood Draw, Other: Pittsburgh Sleep Quality Index (PSQI), Other: Insomnia Severity Index (ISI), Other: SF-12 quality of life surveyParticipants in the intervention group will be provided with a code and website address to participate in this program. This program includes reminder emails and is 6 weeks in duration. Participants will be given a blood draw to measure biomarkers. |
| informational control | Active comparator | Behavioral: Sleep information, Procedure: Blood Draw, Other: Pittsburgh Sleep Quality Index (PSQI), Other: Insomnia Severity Index (ISI), Other: SF-12 quality of life surveyParticipants in the control group will receive weekly emails with sleep information and the health benefits of sleep for 6 weeks.Participants will be given a blood draw to measure biomarkers. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women at high risk of breast cancer due to one or more of the following:
- Ability to access the internet and watch videos online.
- Valid email address.
- Self-reported sleep duration of 6 hours per night or less
Key exclusion criteria (3 listed)
- Previous diagnosis of cancer.
- Lack of ability to read and converse in English.
- Lack of ability to give informed consent.
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 |
|---|---|---|
| GO! To SleepControlled sleep intervention. Provide online education and reminder emails on improving sleep behavior | Behavioural | GO! To Sleep |
| Sleep informationParticipants will receive weekly emails on the health benefits of sleep for 6 weeks | Behavioural | informational control |
| Blood DrawAlso: biomarker measurementblood sample measured for stress and sleep markers | Procedure or surgery | GO! To Sleep, informational control |
| Pittsburgh Sleep Quality Index (PSQI)Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses. | Other | GO! To Sleep, informational control |
| Insomnia Severity Index (ISI) | Other | GO! To Sleep, informational control |
| SF-12 quality of life survey | Other | GO! To Sleep, informational control |
Primary outcome
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Time frame: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured by the PSQI which is a continuous measure from 0 (best) to 21 (worst)
Difference in change in Insomnia Severity Index (ISI) score between groups
Time frame: Change from baseline to post intervention, around 8 weeks after baseline
Sleep quality will be measured with the insomnia severity index (ISI). A validated instrument for sleep quality
Difference in change in sleep duration between groups
Time frame: Change from baseline to post intervention, around 8 weeks after baseline
Sleep duration will be obtained by self-report from responses to the PSQI
5 secondary outcomes
Difference in change of SF-12 score from baseline to post-intervention between groups
Time frame: Change from baseline to 6 months post intervention
Correlation of joint changes in biomarker levels with PSQI and ISI
Time frame: Change from baseline to 6 months post intervention
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups
Time frame: Change from baseline to 6 months post intervention
Difference in change in Insomnia Severity Index (ISI) score between groups
Time frame: Change from baseline to 6 months post intervention
Difference in change in sleep duration between groups
Time frame: Change from baseline to 6 months 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 9 May 2019.
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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.
Cheryl Thompson, PhD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GO! To Sleep, Sleep information and Blood Draw in people with Breast Cancer and Sleep, run by Case Comprehensive Cancer Center 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 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 9 May 2019. 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 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?
Difference in Change in Pittsburgh Sleep Quality Index (PSQI) score between groups (time frame: Change from baseline to post intervention, around 8 weeks after baseline). The study lists 3 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 9 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.