Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2011-07-31
2016-01-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Sleep intervention
Sleep intervention
Sleep intervention
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.
Interventions
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Sleep intervention
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* On active cancer therapy for any cancer
* Pregnant
* Diabetes requiring drug treatment
40 Years
65 Years
FEMALE
Yes
Sponsors
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Canadian Cancer Society (CCS)
OTHER
University of British Columbia
OTHER
Responsible Party
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Carolyn Gotay
Professor
Principal Investigators
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Carolyn Gotay, PhD.
Role: PRINCIPAL_INVESTIGATOR
The Univeristy of British Columbia
Locations
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University of British Columbia
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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2011-701007
Identifier Type: -
Identifier Source: org_study_id