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NCT Number: NCT03444532

Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia

This study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. In total 20 participants will be recruited and randomized to the intervention or control group.

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Key information

Conditions

Cancer Of Prostate Dyssomnias Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Insomnia Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Prostatic Diseases Prostatic Neoplasms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oncology Department

Næstved, Denmark

About this study

This feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. In this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure.

In total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).The intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prostate cancer
  • Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
  • Insomnia
  • Over 18-yers old
  • Understand oral and written Danish
  • Written informed consent

Exclusion criteria

  • Medical assessment that does not allow aerobic exercise
  • Severe cognitive problems
  • Night work during the interventions period
  • Exercise training more than three times a week

Treatment and study plan

12-week aerobic exercise and cognitive-behavioral therapy

Behavioral

12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy

Primary outcomes

  1. Sleep

    Time frame: Change from baseline sleep at 12 weeks

    Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group

Secondary outcomes

  1. Cardiorespiratory fitness

    Time frame: Baseline, 12-weeks

    Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group

  2. Fatigue

    Time frame: Baseline, 12 weeks, 6 month

    Measured by the multidimensional fatigue inventory, to investigate change in fatigue from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  3. Physical activity

    Time frame: Baseline, 12 weeks, 6 month

    Measured by the Physical activity Questionnaire to investigate change in physical activity from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  4. Depression

    Time frame: Baseline, 12 weeks, 6 month

    Measured by the Patient Health Questionnaireto, to investigate change in depression from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  5. Anxiety

    Time frame: Baseline, 12 weeks, 6 month

    Measured by the Generalized Anxiety Disorder Questionnaireto, to investigate change in anxiety from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  6. Stress

    Time frame: Baseline, 12 weeks, 6 month

    Measured by Perceived Stress Scale to investigate change in stress from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  7. Quality of life

    Time frame: Baseline, 12 weeks, 6 month

    Measured by European Organization for Research and Treatment Cancer, to investigate change in quality of life from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  8. Sleep quality

    Time frame: Baseline, 12 weeks, 6 month

    Measured by Pittsburgh Sleep Quality Index, to investigate change in sleep quality from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  9. Sleep pattern

    Time frame: Baseline, 12 weeks, 6 month

    Measured by a sleep diary, to investigate change in sleep pattern from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  10. Insomnia

    Time frame: Baseline, 12 weeks, 6 month

    Measured by Insomnia Severity Index, to investigate change in insomnia from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

  11. Physical activity

    Time frame: Baseline, 12 weeks

    Measured by actigraphy, to investigate change in physical activity from baseline to 12 weeks and the difference in change between intervention - and the control group

Sponsors and collaborators

Lead sponsor

Danish Cancer Society

Other

Registry information

Official study title

Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2018
Registry last updated
May 5, 2020

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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