NCT02609373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

November 17, 2015

Last Update Submit

November 1, 2016

Conditions

Breast Cancer

Keywords

shiftworksleep hygienepreventioninterventionoccupationalbiologicalbreast cancerlifestyle

Outcome Measures

Primary Outcomes (1)

  • Change in sleep quality

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

    Baseline, 6 months

Secondary Outcomes (31)

  • Change in melatonin

    Baseline, 6 months

  • Change in melatonin

    6 months, 12 months

  • Change in melatonin

    Baseline, 12 months

  • Change in cortisol

    Baseline, 6 months

  • Change in cortisol

    6 months, 12 months

  • +26 more secondary outcomes

Other Outcomes (1)

  • Concordance between self-reported sleep quality and other indicators

    Baseline, 6 months, 12 months

Study Arms (1)

Sleep intervention

OTHER

Sleep intervention

Behavioral: Sleep intervention

Interventions

Sleep interventionBEHAVIORAL

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.

Sleep intervention

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of breast cancer
  • On active cancer therapy for any cancer
  • Pregnant
  • Diabetes requiring drug treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsSleep Hygiene

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHealth BehaviorBehavior

Study Officials

  • Carolyn Gotay, PhD.

    The Univeristy of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

July 1, 2011

Primary Completion

April 1, 2015

Study Completion

January 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)