Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Cancer Society
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Sleep
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prostate cancer
- •Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
- •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
Arms & Interventions
12-week aerobic exercise and cognitive-behavioral therapy
12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions
Intervention: 12-week aerobic exercise and cognitive-behavioral therapy (Behavioral)
Control group
Patients assigned to the control group will receive usual care
Outcomes
Primary Outcomes
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
- Quality of life(Baseline, 12 weeks, 6 month)
- Stress(Baseline, 12 weeks, 6 month)
- Physical activity(Baseline, 12 weeks)
- Insomnia(Baseline, 12 weeks, 6 month)
- Fatigue(Baseline, 12 weeks, 6 month)
- Depression(Baseline, 12 weeks, 6 month)
- Cardiorespiratory fitness(Baseline, 12-weeks)
- Anxiety(Baseline, 12 weeks, 6 month)
- Sleep quality(Baseline, 12 weeks, 6 month)
- Sleep pattern(Baseline, 12 weeks, 6 month)
- Physical activity(Baseline, 12 weeks, 6 month)
Investigators
Christoffer Johansen
Professor
Danish Cancer Society