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Improving Cancer-Related Outcomes in Shift Workers (ICOS)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sleep intervention
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring shiftwork, sleep hygiene, prevention, intervention, occupational, biological, breast cancer, lifestyle

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sleep intervention

Arm Description

Sleep intervention

Outcomes

Primary Outcome Measures

Change in sleep quality
Self-reported "good" sleep quality at baseline and 6 months

Secondary Outcome Measures

Change in melatonin
Change in melatonin at baseline and 6 months
Change in melatonin
Change in melatonin at 6 and 12 months
Change in melatonin
Change in melatonin at baseline and 12 months
Change in cortisol
Change in cortisol at baseline and 6 months
Change in cortisol
Change in cortisol at 6 and 12 months
Change in cortisol
Change in cortisol at baseline and 12 months
Change in breast density
Change in breast density at baseline and 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
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
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
Change in Vitamin D
Change in Vitamin D at baseline and 6 months
Change in Vitamin D
Change in Vitamin D at 6 and 12 months
Change in Vitamin D
Change in Vitamin D at baseline and 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 6 months
Change in C-reactive protein
Change in C-reactive protein from 6 to 12 months
Change in C-reactive protein
Change in C-reactive protein from baseline to 12 months
Change in insulin
Change in insulin from baseline to 6 months
Change in insulin
Change in insulin from 6 to 12 months
Change in insulin
Change in insulin from baseline to 12 months
Change in glucose
Change in glucose from baseline to 6 months
Change in glucose
Change in glucose from 6 to 12 months
Change in glucose
Change in glucose from baseline to 12 months
Change in quality of life
Change in quality of life from baseline to 6 months
Change in quality of life
Change in quality of life from 6 months to 12 months
Change in quality of life
Change in quality of life from baseline to 12 months
Intervention Evaluation
Participant satisfaction and perceptions of intervention assessed by semi-structured telephone interview
Change in sleep quality
Self-reported "good" sleep quality at 6 and 12 months
Change in sleep quality
Self-reported "good" sleep quality at baseline and 12 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 6 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at 6 and 12 months
Change in health and lifestyle
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 12 months

Full Information

First Posted
November 17, 2015
Last Updated
November 1, 2016
Sponsor
University of British Columbia
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT02609373
Brief Title
Improving Cancer-Related Outcomes in Shift Workers
Acronym
ICOS
Official Title
Improving Cancer-Related Outcomes in Shift Workers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
shiftwork, sleep hygiene, prevention, intervention, occupational, biological, breast cancer, lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep intervention
Arm Type
Other
Arm Description
Sleep intervention
Intervention Type
Behavioral
Intervention Name(s)
Sleep intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in sleep quality
Description
Self-reported "good" sleep quality at baseline and 6 months
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in melatonin
Description
Change in melatonin at baseline and 6 months
Time Frame
Baseline, 6 months
Title
Change in melatonin
Description
Change in melatonin at 6 and 12 months
Time Frame
6 months, 12 months
Title
Change in melatonin
Description
Change in melatonin at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in cortisol
Description
Change in cortisol at baseline and 6 months
Time Frame
Baseline, 6 months
Title
Change in cortisol
Description
Change in cortisol at 6 and 12 months
Time Frame
6 months, 12 months
Title
Change in cortisol
Description
Change in cortisol at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in breast density
Description
Change in breast density at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in IGF-1 and IGFBP 1,2,3,7
Description
Change in IGF-1 and IGFBP 1,2,3,7 at baseline and 6 months
Time Frame
Baseline, 6 months
Title
Change in IGF-1 and IGFBP 1,2,3,7
Description
Change in IGF-1 and IGFBP 1,2,3,7 at 6 and 12 months
Time Frame
6 months,12 months
Title
Change in IGF-1 and IGFBP 1,2,3,7
Description
Change in IGF-1 and IGFBP 1,2,3,7 at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in Vitamin D
Description
Change in Vitamin D at baseline and 6 months
Time Frame
Baseline, 6 months
Title
Change in Vitamin D
Description
Change in Vitamin D at 6 and 12 months
Time Frame
6 months, 12 months
Title
Change in Vitamin D
Description
Change in Vitamin D at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in C-reactive protein
Description
Change in C-reactive protein from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Change in C-reactive protein
Description
Change in C-reactive protein from 6 to 12 months
Time Frame
6 months and 12 months
Title
Change in C-reactive protein
Description
Change in C-reactive protein from baseline to 12 months
Time Frame
Baseline, 12 months
Title
Change in insulin
Description
Change in insulin from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Change in insulin
Description
Change in insulin from 6 to 12 months
Time Frame
6 months and 12 months
Title
Change in insulin
Description
Change in insulin from baseline to 12 months
Time Frame
Baseline, 12 months
Title
Change in glucose
Description
Change in glucose from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Change in glucose
Description
Change in glucose from 6 to 12 months
Time Frame
6 months and 12 months
Title
Change in glucose
Description
Change in glucose from baseline to 12 months
Time Frame
Baseline, 12 months
Title
Change in quality of life
Description
Change in quality of life from baseline to 6 months
Time Frame
Baseline, 6 months
Title
Change in quality of life
Description
Change in quality of life from 6 months to 12 months
Time Frame
6 months, 12 months
Title
Change in quality of life
Description
Change in quality of life from baseline to 12 months
Time Frame
Baseline,12 months
Title
Intervention Evaluation
Description
Participant satisfaction and perceptions of intervention assessed by semi-structured telephone interview
Time Frame
12 months
Title
Change in sleep quality
Description
Self-reported "good" sleep quality at 6 and 12 months
Time Frame
6 months, 12 months
Title
Change in sleep quality
Description
Self-reported "good" sleep quality at baseline and 12 months
Time Frame
Baseline, 12 months
Title
Change in health and lifestyle
Description
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 6 months
Time Frame
Baseline, 6 months
Title
Change in health and lifestyle
Description
Change in self-reported health and lifestyle assessed by structured questionnaire at 6 and 12 months
Time Frame
6 months, 12 months
Title
Change in health and lifestyle
Description
Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 12 months
Time Frame
Baseline, 12 months
Other Pre-specified Outcome Measures:
Title
Concordance between self-reported sleep quality and other indicators
Description
Comparison of ratings between self-reports, diary data, and actigraph readings at all time points
Time Frame
Baseline, 6 months, 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Gotay, PhD.
Organizational Affiliation
The Univeristy of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T1Z3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Cancer-Related Outcomes in Shift Workers

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