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

Insomnia Clinical Trial

Official title:

Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444532
• Other study ID #: Sleep-Now
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2020
• Source: Danish Cancer Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Prostate
• Insomnia
• Prostatic Neoplasms
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 12-week aerobic exercise and cognitive-behavioral therapy
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy

Locations

Country	Name	City	State
Denmark	Oncology Department	Næstved

Sponsors (1)

Lead Sponsor	Collaborator
Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiorespiratory fitness	Measured by watt max test, to investigate change from baseline to 12 weeks and the difference in change between intervention and the control group	Baseline, 12-weeks
Secondary	Fatigue	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	Baseline, 12 weeks, 6 month
Secondary	Physical activity	Measured by the Physical activity Questionnaire to investigate change in physical activity from baseline to 12 weeks and 6 months follow up and the difference in change between intervention - and the control group	Baseline, 12 weeks, 6 month
Secondary	Depression	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	Baseline, 12 weeks, 6 month
Secondary	Anxiety	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	Baseline, 12 weeks, 6 month
Secondary	Stress	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	Baseline, 12 weeks, 6 month
Secondary	Quality of life	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	Baseline, 12 weeks, 6 month
Secondary	Sleep quality	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	Baseline, 12 weeks, 6 month
Secondary	Sleep pattern	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	Baseline, 12 weeks, 6 month
Secondary	Insomnia	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	Baseline, 12 weeks, 6 month
Secondary	Physical activity	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	Baseline, 12 weeks