Cancer of ProstateNCT03444532
Feasibility Study Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
A study testing 12-week aerobic exercise and cognitive-behavioral therapy in people with Cancer of Prostate and Insomnia, run by Danish Cancer Society at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer of Prostate, Insomnia
- What is being tested?
- 12-week aerobic exercise and cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Mar 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer of Prostate, Insomnia
- Being tested
- 12-week aerobic exercise and cognitive-behavioral therapy
- Medical subject headings
- Prostatic Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week aerobic exercise and cognitive-behavioral therapyBehavioural
12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy | Experimental | 12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions Receives: Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy |
| Control group | No intervention | Patients assigned to the control group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline sleep at 12 weeks
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start2 Mar 2018
- Primary completion31 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoffer Johansen, Danish Cancer Society
- Investigators
- Christoffer Johansen, PhD, Dr.Med, Principal investigator, Danish Cancer Society Research CenterKatrine Løppenthin, PhD, Principal investigator, Danish Cancer Society Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444532
- Sponsor's protocol ID
- Sleep-Now
- Status last verified
- May 2020
- First submitted
- 9 Feb 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Randomized Controlled Trial Testing a Sleep Intervention in Prostate Cancer Patients With Insomnia
- ClinicalTrials.gov ID
- NCT03444532
- Acronym / sponsor ID
- Sleep-Now
- Conditions
- Cancer of Prostate, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy | Experimental | Behavioral: 12-week aerobic exercise and cognitive-behavioral therapy12-week aerobic exercise, two times per week, and cognitive-behavioral therapy for insomnia in total four sessions |
| Control group | No intervention | –Patients assigned to the control group will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate cancer
- Receiving treatment with androgen deprivation therapy or in combination with chemotherapy
- Insomnia
- Over 18-yers old
- Understand oral and written Danish
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week aerobic exercise and cognitive-behavioral therapy12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy | Behavioural | 12-week aerobic exercise and cognitive-behavioral therapy |
Primary outcome
Sleep
Time frame: 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
11 secondary outcomes
Cardiorespiratory fitness
Time frame: Baseline, 12-weeks
Fatigue
Time frame: Baseline, 12 weeks, 6 month
Physical activity
Time frame: Baseline, 12 weeks, 6 month
Depression
Time frame: Baseline, 12 weeks, 6 month
Anxiety
Time frame: Baseline, 12 weeks, 6 month
Stress
Time frame: Baseline, 12 weeks, 6 month
Quality of life
Time frame: Baseline, 12 weeks, 6 month
Sleep quality
Time frame: Baseline, 12 weeks, 6 month
Sleep pattern
Time frame: Baseline, 12 weeks, 6 month
Insomnia
Time frame: Baseline, 12 weeks, 6 month
Physical activity
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Johansen, PhD, Dr.Med principal investigator
Danish Cancer Society Research Center
Katrine Løppenthin, PhD principal investigator
Danish Cancer Society Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week aerobic exercise and cognitive-behavioral therapy in people with Cancer of Prostate and Insomnia, run by Danish Cancer Society at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: Change from baseline sleep at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.