Clinical trial · Interventional
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
NCT03444532CI-TRIAL-00044955completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 12-week aerobic exercise and cognitive-behavioral therapy
- description
- 12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions
- interventionNames
- Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients assigned to the control group will receive usual care
Primary outcomes (1)
- measure
- Sleep
- timeFrame
- Change from baseline sleep at 12 weeks
- description
- Measured by actigraphy, to investigate change in sleep from baseline to 12 weeks and the difference in change between intervention - and the control group
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.