An interventional study of Sleep intervention in Breast Cancer, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 47 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sleep intervention
Behavioral: 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.
Change in sleep quality
Self-reported "good" sleep quality at baseline and 6 months
Time frame: Baseline, 6 months
Change in melatonin
Change in melatonin at baseline and 6 months
Time frame: Baseline, 6 months
Change in melatonin
Change in melatonin at 6 and 12 months
Time frame: 6 months, 12 months
Change in melatonin
Change in melatonin at baseline and 12 months
Time frame: Baseline, 12 months
Change in cortisol
Change in cortisol at baseline and 6 months
Time frame: Baseline, 6 months
Change in cortisol
Change in cortisol at 6 and 12 months
Time frame: 6 months, 12 months
Change in cortisol
Change in cortisol at baseline and 12 months
Time frame: Baseline, 12 months
Change in breast density
Change in breast density at baseline and 12 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 months
Change in Vitamin D
Change in Vitamin D at baseline and 6 months
Time frame: Baseline, 6 months
Change in Vitamin D
Change in Vitamin D at 6 and 12 months
Time frame: 6 months, 12 months
Change in Vitamin D
Change in Vitamin D at baseline and 12 months
Time frame: Baseline, 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 6 months
Time frame: Baseline, 6 months
Change in C-reactive protein
Change in C-reactive protein from 6 to 12 months
Time frame: 6 months and 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 12 months
Time frame: Baseline, 12 months
Change in insulin
Change in insulin from baseline to 6 months
Time frame: Baseline, 6 months
Change in insulin
Change in insulin from 6 to 12 months
Time frame: 6 months and 12 months
Change in insulin
Change in insulin from baseline to 12 months
Time frame: Baseline, 12 months
Change in glucose
Change in glucose from baseline to 6 months
Time frame: Baseline, 6 months
Change in glucose
Change in glucose from 6 to 12 months
Time frame: 6 months and 12 months
Change in glucose
Change in glucose from baseline to 12 months
Time frame: Baseline, 12 months
Change in quality of life
Change in quality of life from baseline to 6 months
Time frame: Baseline, 6 months
Change in quality of life
Change in quality of life from 6 months to 12 months
Time frame: 6 months, 12 months
Change in quality of life
Change in quality of life from baseline to 12 months
Time frame: Baseline,12 months
Intervention Evaluation
Participant satisfaction and perceptions of intervention assessed by semi-structured telephone interview
Time frame: 12 months
Change in sleep quality
Self-reported "good" sleep quality at 6 and 12 months
Time frame: 6 months, 12 months
Change in sleep quality
Self-reported "good" sleep quality at baseline and 12 months
Time frame: Baseline, 12 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 6 months
Time frame: Baseline, 6 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at 6 and 12 months
Time frame: 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
Time frame: Baseline, 12 months
Concordance between self-reported sleep quality and other indicators
Comparison of ratings between self-reports, diary data, and actigraph readings at all time points
Time frame: Baseline, 6 months, 12 months
Plan to share: No
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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University of British Columbia