Prostate CancerSHERE-Relief 2NCT05582759
Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
A study testing teleCBT-I + SH/ReadiWatchTM and SH/ReadiWatchTM in people with Prostate Cancer and Sleep Disturbance, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Sleep Disturbance, Fatigue
- What is being tested?
- teleCBT-I + SH/ReadiWatchTM and SH/ReadiWatchTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to 1 Dec 2023
- 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
- At least 18 years old
- Diagnosed with any stage of prostate cancer
- Receiving androgen deprivation therapy
- Able to speak and read English
- Score >/= 8 on Insomnia Severity Index
Who cannot join
- Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
- Sleep apnea not utilizing/or adherent to CPAP
- Uncontrolled restless legs syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Cancer Center
Kansas City, Kansas, 66160
About this study
Official title: Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT) (SHERE-Relief 2)
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
- Conditions
- Prostate Cancer, Sleep Disturbance, Fatigue, Cognitive Impairment
- Being tested
- teleCBT-I + SH/ReadiWatchTM, SH/ReadiWatchTM
- Keywords
- Prostate Cancer, Sleep Disturbance, Fatigue, Memory, Concentration
- Medical subject headings
- Prostatic Neoplasms, Parasomnias, Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teleCBT-I + SH/ReadiWatchTMBehavioural
Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention
SH/ReadiWatchTMBehavioural
Participants receive real time feedback on sleep metrics and education on sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| SH/ReadiWatchTM | Active comparator | Participants receive real-time feedback on sleep metrics and sleep hygiene education Receives: Behavioral: SH/ReadiWatchTM |
| teleCBT-I + SH/ReadiWatchTM | Experimental | Participants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia Receives: Behavioral: teleCBT-I + SH/ReadiWatchTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by percentage of target sample enrolled
Measured: Through study completion (an average of 24 months)
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Measured: Two months
Feasibility as measured by percent attrition for the four teleCBT-I sessions
Measured: Two months
Secondary outcomes (6)
Change from baseline for participants' ReadiScores
ReadiScores are measured by the SAFTE algorithm developed by the Department of Defense and reflect fatigue and cognitive function (range 0 to 100)
Measured: one month, two months
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
total sleep time in hours per night measured by the SAFTE algorithm.
Measured: one month, two months
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
sleep efficiency equals total sleep time in hours per night divided by time in bed as measured by the SAFTE algorithm.
Measured: one month, two months
Change from baseline in insomnia severity
Measured by the Insomnia Severity Index (total score ranges from 0-28 with higher scores indicating worse insomnia severity.
Measured: one months, two months
Change from baseline in sleep quality
Measured by Pittsburgh Sleep Quality Index (7 component scores calculated from 18 items yielding a global score. Higher scores indicate worse sleep quality
Measured: one months, two months
Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
Measured by items and total score on the Patient Reported Outcomes Management System-29+2 (PROPr). Likert style items with variable ranges, raw scores converted to T-scores and standard deviations.
Measured: one months, two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start24 Oct 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Sponsor
- Investigators
- Jamie Myers, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582759
- Sponsor's protocol ID
- STUDY00148836
- Acronym
- SHERE-Relief 2
- Status last verified
- May 2024
- First submitted
- 15 Sep 2022
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy (ADT) (SHERE-Relief 2)
- ClinicalTrials.gov ID
- NCT05582759
- Acronym / sponsor ID
- SHERE-Relief 2 / STUDY00148836
- Conditions
- Prostate Cancer, Sleep Disturbance, Fatigue, Cognitive Impairment
- Keywords
- Prostate Cancer, Sleep Disturbance, Fatigue, Memory, Concentration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Oct 2022 (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.
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SH/ReadiWatchTM | Active comparator | Behavioral: SH/ReadiWatchTMParticipants receive real-time feedback on sleep metrics and sleep hygiene education |
| teleCBT-I + SH/ReadiWatchTM | Experimental | Behavioral: teleCBT-I + SH/ReadiWatchTMParticipants receive real-time feedback on sleep metrics and sleep hygiene education plus cognitive cognitive behavioral therapy for insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Diagnosed with any stage of prostate cancer
- Receiving androgen deprivation therapy
- Able to speak and read English
- Score >/= 8 on Insomnia Severity Index
Key exclusion criteria (3 listed)
- Diagnosis of Alzheimer's Disease or related dementias, or other conditions that would prevent informed consent
- Sleep apnea not utilizing/or adherent to CPAP
- Uncontrolled restless legs syndrome
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 |
|---|---|---|
| teleCBT-I + SH/ReadiWatchTMParticipants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention | Behavioural | teleCBT-I + SH/ReadiWatchTM |
| SH/ReadiWatchTMParticipants receive real time feedback on sleep metrics and education on sleep hygiene | Behavioural | SH/ReadiWatchTM |
Primary outcome
Feasibility as measured by percentage of target sample enrolled
Time frame: Through study completion (an average of 24 months)
Feasibility as measured by percentage of adherence to ReadiWatch wear time over two months
Time frame: Two months
Feasibility as measured by percent attrition for the four teleCBT-I sessions
Time frame: Two months
6 secondary outcomes
Change from baseline for participants' ReadiScores
Time frame: one month, two months
Change from baseline for participants' sleep metrics for total sleep time (hours per night)
Time frame: one month, two months
Change from baseline for participants' sleep metrics for sleep efficiency (total sleep time divided by time in bed)
Time frame: one month, two months
Change from baseline in insomnia severity
Time frame: one months, two months
Change from baseline in sleep quality
Time frame: one months, two months
Change from baseline in cancer related fatigue, anxiety, depression, and health related quality of life
Time frame: one months, two months
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 17 May 2024.
- Individual participant dataSharing planned: No
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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.
Jamie Myers, PhD principal investigator
University of Kansas Medical 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 teleCBT-I + SH/ReadiWatchTM and SH/ReadiWatchTM in people with Prostate Cancer and Sleep Disturbance, run by University of Kansas Medical Center at 1 site in United States.
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 5 inclusion and 3 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 17 May 2024. 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 United States. 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?
Feasibility as measured by percentage of target sample enrolled (time frame: Through study completion (an average of 24 months)). The study lists 3 primary outcomes in all. 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 17 May 2024.