An interventional study of 12-week aerobic exercise and cognitive-behavioral therapy in Cancer of Prostate and Insomnia, sponsored by Danish Cancer Society. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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
Patients assigned to the control group will receive usual care
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
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
Time frame: Change from baseline sleep at 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 12 weeks
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danish Cancer Society