Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
NCT ID: NCT03444532
Last Updated: 2020-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2018-03-02
2019-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
12-week aerobic exercise and cognitive-behavioral therapy
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Control group
Patients assigned to the control group will receive usual care
No interventions assigned to this group
Interventions
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12-week aerobic exercise and cognitive-behavioral therapy
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe cognitive problems
* Night work during the interventions period
* Exercise training more than three times a week
18 Years
MALE
No
Sponsors
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Danish Cancer Society
OTHER
Responsible Party
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Christoffer Johansen
Professor
Principal Investigators
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Christoffer Johansen, PhD, Dr.Med
Role: PRINCIPAL_INVESTIGATOR
Danish Cancer Society Research Center
Katrine Løppenthin, PhD
Role: PRINCIPAL_INVESTIGATOR
Danish Cancer Society Research Center
Locations
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Oncology Department
Næstved, , Denmark
Countries
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Other Identifiers
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Sleep-Now
Identifier Type: -
Identifier Source: org_study_id
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