Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Sponsor study identifier
interventional
12
1 country
1
Study Start
March 2, 2018
Actual (reported)Primary Completion
March 31, 2019
Actual (reported)Study Completion
May 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2018
Actual (reported)February 23, 2018
Actual (reported)March 2, 2018
Actual (reported)March 31, 2019
Actual (reported)May 31, 2019
Actual (reported)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
Cardiorespiratory fitness
Baseline, 12-weeks
Fatigue
Baseline, 12 weeks, 6 month
Physical activity
Baseline, 12 weeks, 6 month
Depression
Baseline, 12 weeks, 6 month
Anxiety
Baseline, 12 weeks, 6 month
12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions
Patients assigned to the control group will receive usual care
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Oncology Department
Næstved, Denmark
Christoffer Johansen, PhD, Dr.Med
Danish Cancer Society Research Center
Katrine Løppenthin, PhD
Danish Cancer Society Research Center
12 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2018
First Posted
February 23, 2018
Study Start
March 2, 2018
Actual (reported)The Effect of Exercise on Tumor Hypoxia in Men With Localized Prostate Cancer Undergoing Radical Prostatectomy.
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2019
Actual (reported)Study Completion
May 31, 2019
Actual (reported)Last Updated
May 5, 2020
Record last verified: 2020-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: