Breast CancerICOSNCT02609373
Improving Cancer-Related Outcomes in Shift Workers
A study testing Sleep intervention in people with Breast Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
Shift work with circadian disruption has been linked with increased breast cancer incidence. The mechanisms for this effect are not yet completely understood. This study evaluates the impact of a previously developed sleep intervention in shift workers at risk of breast cancer; and assesses mediating variables that… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jan 2016
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 40-65 years
- Working or living in Greater Vancouver Area
- Read and understand English
- Work rotating or permanent night shift at least 3 times per month, for at least 2 years
- Received a screening mammogram within the past 3 years
Who cannot join
- History of breast cancer
- On active cancer therapy for any cancer
- Pregnant
- Diabetes requiring drug treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T1Z3
About this study
Shift work with circadian disruption has been linked with increased breast cancer incidence. The mechanisms for this effect are not yet completely understood.
This study evaluates the impact of a previously developed sleep intervention in shift workers at risk of breast cancer; and assesses mediating variables that may explain the relationship between shift work and breast cancer.
Read more
A sample of women night shift workers were provided with a sleep intervention. The intervention is a standard approach used in a sleep clinic and is delivered by telephone by a trained intervener.
Hypothesis: The intervention will improve sleep in women night shift workers, which will in turn have a positive impact on biological and behavioural risk factors associated with breast cancer and quality of life.
Read the detailed description
47 female night shift workers completed a sleep intervention. The intervention follows an established sleep therapy protocol. Assessments at baseline, 6 and 12 months include mammographic density and possible mediating variables known to be linked to breast cancer risk including behavioural, biometric, and biological measures. Behavioural and self-report measures of sleep quality and physical activity are assessed as well as self-reported chronotype and quality of life.
The intervention is a multi-session intervention using cognitive behavioural principles to increase healthy sleep by addressing a variety of behaviours that may influence sleep quality and quantity, based an established telephone-based protocol used at the UBC Hospital Sleep Disorders Clinic. It includes 10 telephone sessions spaced over a 6-month period, and 2 additional booster sessions at 8 and 10 months. Participants are given a sleep diary at baseline to complete for 2 weeks before the sleep hygiene telephone counseling session begins.
The intervention protocol incorporates sleep assessment, maintaining a sleep diary and use of an actiwatch (to measure sleep and physical activity), sleep hygiene (i.e., controlling behavioural and environmental factors that affect sleep), stimulus control therapy (i.e., teaching individuals how to eliminate behaviours that are incompatible with sleep), sleep restriction therapy (i.e., teaching how to limit time in bed to time asleep), cognitive restructuring (i.e., modifying non-adaptive thoughts and triggers for insomnia), and relapse prevention. The structured counseling protocol includes concrete exercises and activities, questions and answers, and problem solving strategies.
Medication use is not part of this protocol; if participants wish to explore pharmacologic approaches, they are advised to consult with their physicians. Although some shift workers have received care from the Sleep Clinic in the past, there has not been a systematic focus on this group.
The project manager conducts a telephone-based evaluation of the intervention 6 months post-sleep intervention. Blood and salivary samples are collected using standardized data collection methods at baseline, 6, and 12 months, and mammographic films are collected at baseline and 12 months.
- Conditions
- Breast Cancer
- Being tested
- Sleep intervention
- Keywords
- shiftwork, sleep hygiene, prevention, intervention, occupational, biological, breast cancer, lifestyle
- 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 interventionBehavioural
Session 1: Intervener \& participant review 2-week sleep diary and actigraph data. Provide individualized sleep hygiene prescription.
Session 2: Review sleep diary; calculate sleep efficiency; identify adjustments needed.
Session 3: Review sleep-related vs. stress-related symptoms. Develop plan for sleep-related symptoms and discuss "Sleep Restriction with Relaxation Exercises." Session 4: Reinforce progress and make corrections as required. If Sleep Restriction is not working, Stimulus Control is introduced.
Session 5-10: Provide reinforcement, assess adherence, answer questions, and offer encouragement and monitoring, including alterations as required.
Booster sessions: At 8 \& 10 months: reinforcement, question answering, encouragement and monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Sleep intervention | Other | Sleep intervention Receives: Behavioral: Sleep intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep quality
Self-reported "good" sleep quality at baseline and 6 months
Measured: Baseline, 6 months
Secondary outcomes (31)
Change in melatonin
Change in melatonin at baseline and 6 months
Measured: Baseline, 6 months
Change in melatonin
Change in melatonin at 6 and 12 months
Measured: 6 months, 12 months
Change in melatonin
Change in melatonin at baseline and 12 months
Measured: Baseline, 12 months
Change in cortisol
Change in cortisol at baseline and 6 months
Measured: Baseline, 6 months
Change in cortisol
Change in cortisol at 6 and 12 months
Measured: 6 months, 12 months
Change in cortisol
Change in cortisol at baseline and 12 months
Measured: Baseline, 12 months
Change in breast density
Change in breast density at baseline and 12 months
Measured: Baseline, 12 months
Change in IGF-1 and IGFBP 1,2,3,7
Change in IGF-1 and IGFBP 1,2,3,7 at baseline and 6 months
Measured: Baseline, 6 months
Change in IGF-1 and IGFBP 1,2,3,7
Change in IGF-1 and IGFBP 1,2,3,7 at 6 and 12 months
Measured: 6 months,12 months
Change in IGF-1 and IGFBP 1,2,3,7
Change in IGF-1 and IGFBP 1,2,3,7 at baseline and 12 months
Measured: Baseline, 12 months
Change in Vitamin D
Change in Vitamin D at baseline and 6 months
Measured: Baseline, 6 months
Change in Vitamin D
Change in Vitamin D at 6 and 12 months
Measured: 6 months, 12 months
Change in Vitamin D
Change in Vitamin D at baseline and 12 months
Measured: Baseline, 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 6 months
Measured: Baseline, 6 months
Change in C-reactive protein
Change in C-reactive protein from 6 to 12 months
Measured: 6 months and 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 12 months
Measured: Baseline, 12 months
Change in insulin
Change in insulin from baseline to 6 months
Measured: Baseline, 6 months
Change in insulin
Change in insulin from 6 to 12 months
Measured: 6 months and 12 months
Change in insulin
Change in insulin from baseline to 12 months
Measured: Baseline, 12 months
Change in glucose
Change in glucose from baseline to 6 months
Measured: Baseline, 6 months
Change in glucose
Change in glucose from 6 to 12 months
Measured: 6 months and 12 months
Change in glucose
Change in glucose from baseline to 12 months
Measured: Baseline, 12 months
Change in quality of life
Change in quality of life from baseline to 6 months
Measured: Baseline, 6 months
Change in quality of life
Change in quality of life from 6 months to 12 months
Measured: 6 months, 12 months
Change in quality of life
Change in quality of life from baseline to 12 months
Measured: Baseline,12 months
Intervention Evaluation
Participant satisfaction and perceptions of intervention assessed by semi-structured telephone interview
Measured: 12 months
Change in sleep quality
Self-reported "good" sleep quality at 6 and 12 months
Measured: 6 months, 12 months
Change in sleep quality
Self-reported "good" sleep quality at baseline and 12 months
Measured: Baseline, 12 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 6 months
Measured: Baseline, 6 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at 6 and 12 months
Measured: 6 months, 12 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 12 months
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJul 2011
- Primary completionApr 2015
- Study completionJan 2016
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 University of British ColumbiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Principal investigator, Carolyn Gotay, University of British Columbia
- Investigators
- Carolyn Gotay, PhD., Principal investigator, The Univeristy of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609373
- Sponsor's protocol ID
- 2011-701007
- Acronym
- ICOS
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer-Related Outcomes in Shift Workers
- ClinicalTrials.gov ID
- NCT02609373
- Acronym / sponsor ID
- ICOS / 2011-701007
- Conditions
- Breast Cancer
- Keywords
- shiftwork, sleep hygiene, prevention, intervention, occupational, biological, breast cancer, lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Jul 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 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.
Shift work with circadian disruption has been linked with increased breast cancer incidence. The mechanisms for this effect are not yet completely understood.
This study evaluates the impact of a previously developed sleep intervention in shift workers at risk of breast cancer; and assesses mediating variables that may explain the relationship between shift work and breast cancer.
A sample of women night shift workers were provided with a sleep intervention. The intervention is a standard approach used in a sleep clinic and is delivered by telephone by a trained intervener.
Hypothesis: The intervention will improve sleep in women night shift workers, which will in turn have a positive impact on biological and behavioural risk factors associated with breast cancer and quality of life.
Detailed description
47 female night shift workers completed a sleep intervention. The intervention follows an established sleep therapy protocol. Assessments at baseline, 6 and 12 months include mammographic density and possible mediating variables known to be linked to breast cancer risk including behavioural, biometric, and biological measures. Behavioural and self-report measures of sleep quality and physical activity are assessed as well as self-reported chronotype and quality of life.
The intervention is a multi-session intervention using cognitive behavioural principles to increase healthy sleep by addressing a variety of behaviours that may influence sleep quality and quantity, based an established telephone-based protocol used at the UBC Hospital Sleep Disorders Clinic. It includes 10 telephone sessions spaced over a 6-month period, and 2 additional booster sessions at 8 and 10 months. Participants are given a sleep diary at baseline to complete for 2 weeks before the sleep hygiene telephone counseling session begins.
The intervention protocol incorporates sleep assessment, maintaining a sleep diary and use of an actiwatch (to measure sleep and physical activity), sleep hygiene (i.e., controlling behavioural and environmental factors that affect sleep), stimulus control therapy (i.e., teaching individuals how to eliminate behaviours that are incompatible with sleep), sleep restriction therapy (i.e., teaching how to limit time in bed to time asleep), cognitive restructuring (i.e., modifying non-adaptive thoughts and triggers for insomnia), and relapse prevention. The structured counseling protocol includes concrete exercises and activities, questions and answers, and problem solving strategies.
Medication use is not part of this protocol; if participants wish to explore pharmacologic approaches, they are advised to consult with their physicians. Although some shift workers have received care from the Sleep Clinic in the past, there has not been a systematic focus on this group.
The project manager conducts a telephone-based evaluation of the intervention 6 months post-sleep intervention. Blood and salivary samples are collected using standardized data collection methods at baseline, 6, and 12 months, and mammographic films are collected at baseline and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep intervention | Other | Behavioral: Sleep interventionSleep intervention |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 40-65 years
- Working or living in Greater Vancouver Area
- Read and understand English
- Work rotating or permanent night shift at least 3 times per month, for at least 2 years
- Received a screening mammogram within the past 3 years
Key exclusion criteria (4 listed)
- History of breast cancer
- On active cancer therapy for any cancer
- Pregnant
- Diabetes requiring drug treatment
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 interventionSession 1: Intervener \& participant review 2-week sleep diary and actigraph data. Provide individualized sleep hygiene prescription. Session 2: Review sleep diary; calculate sleep efficiency; identify adjustments needed. Session 3: Review sleep-related vs. stress-related symptoms. Develop plan for sleep-related symptoms and discuss "Sleep Restriction with Relaxation Exercises." Session 4: Reinforce progress and make corrections as required. If Sleep Restriction is not working, Stimulus Control is introduced. Session 5-10: Provide reinforcement, assess adherence, answer questions, and offer encouragement and monitoring, including alterations as required. Booster sessions: At 8 \& 10 months: reinforcement, question answering, encouragement and monitoring. | Behavioural | Sleep intervention |
Primary outcome
Change in sleep quality
Time frame: Baseline, 6 months
Self-reported "good" sleep quality at baseline and 6 months
31 secondary outcomes
Change in melatonin
Time frame: Baseline, 6 months
Change in melatonin
Time frame: 6 months, 12 months
Change in melatonin
Time frame: Baseline, 12 months
Change in cortisol
Time frame: Baseline, 6 months
Change in cortisol
Time frame: 6 months, 12 months
Change in cortisol
Time frame: Baseline, 12 months
Change in breast density
Time frame: Baseline, 12 months
Change in IGF-1 and IGFBP 1,2,3,7
Time frame: Baseline, 6 months
Change in IGF-1 and IGFBP 1,2,3,7
Time frame: 6 months,12 months
Change in IGF-1 and IGFBP 1,2,3,7
Time frame: Baseline, 12 months
Change in Vitamin D
Time frame: Baseline, 6 months
Change in Vitamin D
Time frame: 6 months, 12 months
Change in Vitamin D
Time frame: Baseline, 12 months
Change in C-reactive protein
Time frame: Baseline, 6 months
Change in C-reactive protein
Time frame: 6 months and 12 months
Change in C-reactive protein
Time frame: Baseline, 12 months
Change in insulin
Time frame: Baseline, 6 months
Change in insulin
Time frame: 6 months and 12 months
Change in insulin
Time frame: Baseline, 12 months
Change in glucose
Time frame: Baseline, 6 months
Change in glucose
Time frame: 6 months and 12 months
Change in glucose
Time frame: Baseline, 12 months
Change in quality of life
Time frame: Baseline, 6 months
Change in quality of life
Time frame: 6 months, 12 months
Change in quality of life
Time frame: Baseline,12 months
Intervention Evaluation
Time frame: 12 months
Change in sleep quality
Time frame: 6 months, 12 months
Change in sleep quality
Time frame: Baseline, 12 months
Change in health and lifestyle
Time frame: Baseline, 6 months
Change in health and lifestyle
Time frame: 6 months, 12 months
Change in health and lifestyle
Time frame: Baseline, 12 months
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 3 Nov 2016.
- 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.
Carolyn Gotay, PhD. principal investigator
The Univeristy of British Columbia
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 intervention in people with Breast Cancer, run by University of British Columbia at 1 site in Canada.
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 4 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 3 Nov 2016. 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 Canada. 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?
Change in sleep quality (time frame: Baseline, 6 months). 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 3 Nov 2016.