Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 23, 2018
CompletedStudy Start
First participant enrolled
March 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedMay 5, 2020
May 1, 2020
1.1 years
February 9, 2018
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
12-week aerobic exercise and cognitive-behavioral therapy
EXPERIMENTAL12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions
Control group
NO INTERVENTIONPatients assigned to the control group will receive usual care
Interventions
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncology Department
Næstved, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoffer Johansen, PhD, Dr.Med
Danish Cancer Society Research Center
- PRINCIPAL INVESTIGATOR
Katrine Løppenthin, PhD
Danish Cancer Society Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 23, 2018
Study Start
March 2, 2018
Primary Completion
March 31, 2019
Study Completion
May 31, 2019
Last Updated
May 5, 2020
Record last verified: 2020-05