Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia

Not Applicable

Completed

• Conditions: Cancer of Prostate; Insomnia
• Interventions: Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy

• Registration Number: NCT03444532
• Lead Sponsor: Danish Cancer Society

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 Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-23
• Study Start: 2018-03-02
• Primary Completion: 2019-03-31
• Study Completion: 2019-05-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-04
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-week aerobic exercise and cognitive-behavioral therapy	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

Primary Outcome Measures

Name	Time	Method
Sleep	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 Outcome Measures

Name	Time	Method
Quality of life	Baseline, 12 weeks, 6 month	Measured by European Organization for Research and Treatment Cancer, to investigate change in quality of life from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Stress	Baseline, 12 weeks, 6 month	Measured by Perceived Stress Scale to investigate change in stress from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Physical activity	Baseline, 12 weeks	Measured by actigraphy, to investigate change in physical activity from baseline to 12 weeks and the difference in change between intervention - and the control group
Insomnia	Baseline, 12 weeks, 6 month	Measured by Insomnia Severity Index, to investigate change in insomnia from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Fatigue	Baseline, 12 weeks, 6 month	Measured by the multidimensional fatigue inventory, to investigate change in fatigue from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Depression	Baseline, 12 weeks, 6 month	Measured by the Patient Health Questionnaireto, to investigate change in depression from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Cardiorespiratory fitness	Baseline, 12-weeks	Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group
Anxiety	Baseline, 12 weeks, 6 month	Measured by the Generalized Anxiety Disorder Questionnaireto, to investigate change in anxiety from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Sleep quality	Baseline, 12 weeks, 6 month	Measured by Pittsburgh Sleep Quality Index, to investigate change in sleep quality from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group
Sleep pattern	Baseline, 12 weeks, 6 month	Measured by a sleep diary, to investigate change in sleep pattern from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group

Trial Locations

Locations (1)

Oncology Department; 🇩🇰 Næstved, Denmark