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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Cancer of Prostate
• Intervention / Treatment: Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Næstved, Denmark
    • Oncology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy; 12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
NO_INTERVENTION: Control group; Patients assigned to the control group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Danish Cancer Society
• Investigators: Principal Investigator: Christoffer Johansen, PhD, Dr.Med, Danish Cancer Society Research Center; Principal Investigator: Katrine Løppenthin, PhD, Danish Cancer Society Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Sleep-Now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No