Overview

This trial has been completed.

Condition breast cancer
Treatment sleep intervention
Sponsor University of British Columbia
Collaborator Canadian Cancer Society Research Institute (CCSRI)
Start date July 2011
End date April 2015
Trial size 47 participants
Trial identifier NCT02609373, 2011-701007

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
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.

Primary Outcomes

Measure
Change in sleep quality
time frame: Baseline, 6 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 40 years up to 65 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - History of breast cancer - On active cancer therapy for any cancer - Pregnant - Diabetes requiring drug treatment

Additional Information

Official title Improving Cancer-Related Outcomes in Shift Workers
Principal investigator Carolyn Gotay, PhD.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.