Cancer of Prostate, Insomnia
Conditions
Brief summary
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
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.
Interventions
BEHAVIORAL12-week aerobic exercise and cognitive-behavioral therapy
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Sponsors
Danish Cancer Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep | 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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 |
| Physical activity | 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 |
| Depression | 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 |
| Anxiety | 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 |
| Cardiorespiratory fitness | 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 |
| Quality of life | 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 |
| Sleep quality | 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 |
| Sleep pattern | 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 |
| Insomnia | 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 |
| Stress | 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 |
Countries
Denmark
Outcome results
None listed