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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer of Prostate, Insomnia

Intervention / Treatment
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* Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-week aerobic exercise and cognitive-behavioral therapy<br>12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions | Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy<br>* 12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy<br>|
| No Intervention: Control group<br>Patients assigned to the control group will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group | Change from baseline sleep at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness | Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group | Baseline, 12-weeks | 
| Fatigue | 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 | Baseline, 12 weeks, 6 month | 
| Physical activity | 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 | Baseline, 12 weeks, 6 month | 
| Depression | 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 | Baseline, 12 weeks, 6 month | 
| Anxiety | 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 | Baseline, 12 weeks, 6 month | 
| Stress | 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 | Baseline, 12 weeks, 6 month | 
| Quality of life | 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 | Baseline, 12 weeks, 6 month | 
| Sleep quality | 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 | Baseline, 12 weeks, 6 month | 
| Sleep pattern | 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 | Baseline, 12 weeks, 6 month | 
| Insomnia | 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 | Baseline, 12 weeks, 6 month | 
| Physical activity | 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 | Baseline, 12 weeks |