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Completed

NCT Number: NCT02609373

Improving Cancer-Related Outcomes in Shift Workers

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.

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep intervention

Behavioral

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

  1. Change in sleep quality

    Time frame: Baseline, 6 months

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

Secondary outcomes

  1. Change in melatonin

    Time frame: Baseline, 6 months

    Change in melatonin at baseline and 6 months

  2. Change in melatonin

    Time frame: 6 months, 12 months

    Change in melatonin at 6 and 12 months

  3. Change in melatonin

    Time frame: Baseline, 12 months

    Change in melatonin at baseline and 12 months

  4. Change in cortisol

    Time frame: Baseline, 6 months

    Change in cortisol at baseline and 6 months

  5. Change in cortisol

    Time frame: 6 months, 12 months

    Change in cortisol at 6 and 12 months

  6. Change in cortisol

    Time frame: Baseline, 12 months

    Change in cortisol at baseline and 12 months

  7. Change in breast density

    Time frame: Baseline, 12 months

    Change in breast density at baseline and 12 months

  8. 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 at baseline and 6 months

  9. 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 at 6 and 12 months

  10. Change in IGF-1 and IGFBP 1,2,3,7

    Time frame: Baseline, 12 months

    Change in IGF-1 and IGFBP 1,2,3,7 at baseline and 12 months

  11. Change in Vitamin D

    Time frame: Baseline, 6 months

    Change in Vitamin D at baseline and 6 months

  12. Change in Vitamin D

    Time frame: 6 months, 12 months

    Change in Vitamin D at 6 and 12 months

  13. Change in Vitamin D

    Time frame: Baseline, 12 months

    Change in Vitamin D at baseline and 12 months

  14. Change in C-reactive protein

    Time frame: Baseline, 6 months

    Change in C-reactive protein from baseline to 6 months

  15. Change in C-reactive protein

    Time frame: 6 months and 12 months

    Change in C-reactive protein from 6 to 12 months

  16. Change in C-reactive protein

    Time frame: Baseline, 12 months

    Change in C-reactive protein from baseline to 12 months

  17. Change in insulin

    Time frame: Baseline, 6 months

    Change in insulin from baseline to 6 months

  18. Change in insulin

    Time frame: 6 months and 12 months

    Change in insulin from 6 to 12 months

  19. Change in insulin

    Time frame: Baseline, 12 months

    Change in insulin from baseline to 12 months

  20. Change in glucose

    Time frame: Baseline, 6 months

    Change in glucose from baseline to 6 months

  21. Change in glucose

    Time frame: 6 months and 12 months

    Change in glucose from 6 to 12 months

  22. Change in glucose

    Time frame: Baseline, 12 months

    Change in glucose from baseline to 12 months

  23. Change in quality of life

    Time frame: Baseline, 6 months

    Change in quality of life from baseline to 6 months

  24. Change in quality of life

    Time frame: 6 months, 12 months

    Change in quality of life from 6 months to 12 months

  25. Change in quality of life

    Time frame: Baseline,12 months

    Change in quality of life from baseline to 12 months

  26. Intervention Evaluation

    Time frame: 12 months

    Participant satisfaction and perceptions of intervention assessed by semi-structured telephone interview

  27. Change in sleep quality

    Time frame: 6 months, 12 months

    Self-reported "good" sleep quality at 6 and 12 months

  28. Change in sleep quality

    Time frame: Baseline, 12 months

    Self-reported "good" sleep quality at baseline and 12 months

  29. Change in health and lifestyle

    Time frame: Baseline, 6 months

    Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 6 months

  30. Change in health and lifestyle

    Time frame: 6 months, 12 months

    Change in self-reported health and lifestyle assessed by structured questionnaire at 6 and 12 months

  31. Change in health and lifestyle

    Time frame: Baseline, 12 months

    Change in self-reported health and lifestyle assessed by structured questionnaire at baseline and 12 months

Other outcomes

  1. Concordance between self-reported sleep quality and other indicators

    Time frame: Baseline, 6 months, 12 months

    Comparison of ratings between self-reports, diary data, and actigraph readings at all time points

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Acronym: ICOS

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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