Prostate CancerNCT05318131
Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
A study testing Sleep and Lifestyle Advice Website and Surveys and Sleep Monitors in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sleep and Lifestyle Advice Website and Surveys and Sleep Monitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 12 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult U.S. male age >18 with prostate cancer OR
- Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND
- Telephone and internet access AND
- Able to read, comprehend, and sign informed consent in English AND
- Perceived deficits in sleep, nutrition, and/or physical activity
Who cannot join
- Age <18 years
- Not English proficient
- No or irregular access to the same telephone number and/or mailing address
- No or less than weekly access to the internet
- Patients who do not have a diagnosis of prostate cancer
- Caregivers/family members for a condition other than prostate cancer
Show all 9Show fewer
- Mental or cognitive impairment that interferes with ability to provide informed consent
- Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate)
- Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.
Read the detailed description
The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle.
- Conditions
- Prostate Cancer
- Being tested
- Sleep and Lifestyle Advice Website, Surveys and Sleep Monitors
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and Lifestyle Advice WebsiteOther
Participants will be asked to view a website at least once a week for 3 months (remotely). The website includes information about exercise, nutrition and sleep. Participants will also have a check-in call with a health coach at 6 weeks, and will be sent email newsletters at approximately 1 and 2 months with additional information about sleep, nutrition, and exercise.
Surveys and Sleep MonitorsOther
At baseline and at 3 months, participants will be asked to complete online surveys and to wear an ActiGraph sleep monitor for one week. ActiGraph sleep monitors are wristbands that measure continuous sleep/wake activity information. The recorded ActiGraph data is deidentified and no individual personally identifiable information is collected. A unique serial number identifies each wrist monitor. At the end of the study, participants will also have a telephone exit interview with the study team to provide feedback on their progress during the study and about the website.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Prospective Study | Experimental | Not described Receives: Other: Sleep and Lifestyle Advice Website; Other: Surveys and Sleep Monitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Efficiency
The study team will use ActiGraph software to calculate device-based measures of sleep efficiency. Sleep efficiency is the ratio of total sleep time (total time spent asleep) to time in bed and is reported as a percentage (total sleep time / time in bed x 100).
Measured: Baseline, 3 months
Change in Number of Awakenings After Sleep Onset
The study team will use ActiGraph software to calculate device-based measure number of awakenings (when a participant wakes up) after sleep onset (the transition from wakefulness into sleep).
Measured: Baseline, 3 months
Change in Sleep Duration
The study team will use ActiGraph software to calculate device-based measures of sleep duration
Measured: Baseline, 3 months
Change in Sleep Hygiene Index (SHI) Score
SHI is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.
Measured: Baseline, 3 months
Change in Pittsburgh Sleep Quality Index (PSQI) Score
PSQI contains 19 self-reported questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score "0" indicates no difficulty, while "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points; the higher the score, the more severe the difficulties in all areas.
Measured: Baseline, 3 months
Change in Insomnia Severity Index Score
The Insomnia Severity Index has 7 questions, each rated on a 5-point Likert scale (0-4). The total score range is 0-28; the higher the score, the more severe the insomnia. 0-7 = no clinical significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinical insomnia (moderate severity), and 22-28 = clinical insomnia (severe)
Measured: Baseline, 3 months
Secondary outcomes (4)
Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day
The study team will use ActiGraph's GT3X tri-axial accelerometer and ActiLife software to calculate device-based measures of physical activity. Daily MVPA will be based on least 4 days of at least 10 hours of device wear time. A higher number of minutes of MVPA indicates more physical activity. Among U.S. adults aged 60 years or older, mean number of minutes per day of MVPA ranges from 10.8 to 106.8.
Measured: Baseline, 3 months
Change in device-based step counts per day
The study team will use ActiLife software to calculate step counts per day. Daily steps will be based on at least 4 days of at least 10 hours of device wear time. A higher step count indicates more physical activity. Based on U.S. population samples, normative daily step count ranges are 41 to 12,780 steps for men aged 60 years or older and 55 to 9,735 for women aged 60 years or older.
Measured: Baseline, 3 months
Change in self-reported total physical activity MET-minutes per day
The study team will use the International Physical Activity Questionnaire short form (IPAQ-SF). It will be used to assess time spent in 3 specific types of activity over the previous 7 days: vigorous-intensity activities, moderate-intensity activities, and walking. Time spent in these 3 activity types will be combined to calculate total physical activity minutes per day, a continuous variable with a plausible range of 0 to 960. Then, the study team will apply metabolic equivalents by intensity to calculate total physical activity MET-minutes per day.
Measured: Baseline, 3 months
Change in Dietary Consumption
The study team will use a food frequency questionnaire to measure servings per week of foods. Each food category is measured in never (lowest), once per month, 2-3 times last month, 1 time per week, 2 times per week, 3-4 times per week, 5-6 per week, 1 time per day, 2-3 times per day, 4-5 times per day, and 6+ times per day (highest).
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start30 Aug 2022
- Primary completion26 Sep 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health
- Responsible party
- Sponsor
- Investigators
- Stacy Loeb, MD MSc, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318131
- Sponsor's protocol ID
- 20-00078
- Status last verified
- Sep 2024
- First submitted
- 23 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Publications
Loeb S, Robbins R, Sanchez-Nolasco T, Byrne N, Ruan A, Rivera A, Gupta N, Kenfield SA, Chan JM, Van Blarigan EL, Carter P, Jean-Louis G, Orstad SL. Sleep and health improvement programme (SHIP) for patients with prostate cancer and caregivers. BJUI Compass. 2024 Aug 31;5(10):976-985. doi: 10.1002/bco2.435. eCollection 2024 Oct.
PubMed 39416756
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
- ClinicalTrials.gov ID
- NCT05318131
- Acronym / sponsor ID
- 20-00078
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- New York State Department of Health
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 8 Apr 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.
The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.
Detailed description
The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Prospective Study | Experimental | Other: Sleep and Lifestyle Advice Website, Other: Surveys and Sleep Monitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult U.S. male age >18 with prostate cancer OR
- Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND
- Telephone and internet access AND
- Able to read, comprehend, and sign informed consent in English AND
- Perceived deficits in sleep, nutrition, and/or physical activity
Key exclusion criteria (9 listed)
- Age <18 years
- Not English proficient
- No or irregular access to the same telephone number and/or mailing address
- No or less than weekly access to the internet
- Patients who do not have a diagnosis of prostate cancer
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 |
|---|---|---|
| Sleep and Lifestyle Advice WebsiteParticipants will be asked to view a website at least once a week for 3 months (remotely). The website includes information about exercise, nutrition and sleep. Participants will also have a check-in call with a health coach at 6 weeks, and will be sent email newsletters at approximately 1 and 2 months with additional information about sleep, nutrition, and exercise. | Other | Single Arm Prospective Study |
| Surveys and Sleep MonitorsAt baseline and at 3 months, participants will be asked to complete online surveys and to wear an ActiGraph sleep monitor for one week. ActiGraph sleep monitors are wristbands that measure continuous sleep/wake activity information. The recorded ActiGraph data is deidentified and no individual personally identifiable information is collected. A unique serial number identifies each wrist monitor. At the end of the study, participants will also have a telephone exit interview with the study team to provide feedback on their progress during the study and about the website. | Other | Single Arm Prospective Study |
Primary outcome
Change in Sleep Efficiency
Time frame: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measures of sleep efficiency. Sleep efficiency is the ratio of total sleep time (total time spent asleep) to time in bed and is reported as a percentage (total sleep time / time in bed x 100).
Change in Number of Awakenings After Sleep Onset
Time frame: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measure number of awakenings (when a participant wakes up) after sleep onset (the transition from wakefulness into sleep).
Change in Sleep Duration
Time frame: Baseline, 3 months
The study team will use ActiGraph software to calculate device-based measures of sleep duration
Change in Sleep Hygiene Index (SHI) Score
Time frame: Baseline, 3 months
SHI is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, 3 months
PSQI contains 19 self-reported questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points. In all cases, a score "0" indicates no difficulty, while "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points; the higher the score, the more severe the difficulties in all areas.
Change in Insomnia Severity Index Score
Time frame: Baseline, 3 months
The Insomnia Severity Index has 7 questions, each rated on a 5-point Likert scale (0-4). The total score range is 0-28; the higher the score, the more severe the insomnia. 0-7 = no clinical significant insomnia, 8-14 = subthreshold insomnia, 15-21 = clinical insomnia (moderate severity), and 22-28 = clinical insomnia (severe)
4 secondary outcomes
Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day
Time frame: Baseline, 3 months
Change in device-based step counts per day
Time frame: Baseline, 3 months
Change in self-reported total physical activity MET-minutes per day
Time frame: Baseline, 3 months
Change in Dietary Consumption
Time frame: Baseline, 3 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 19 Sep 2024.
- Results publication: PubMed 39416756Loeb S, Robbins R, Sanchez-Nolasco T, Byrne N, Ruan A, Rivera A, Gupta N, Kenfield SA, Chan JM, Van Blarigan EL, Carter P, Jean-Louis G, Orstad SL. Sleep and health improvement programme (SHIP) for patients with prostate cancer and caregivers. BJUI Compass. 2024 Aug 31;5(10):976-985. doi: 10.1002/bco2.435. eCollection 2024 Oct.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Stacy Loeb, MD MSc principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and Lifestyle Advice Website and Surveys and Sleep Monitors in people with Prostate Cancer, run by NYU Langone Health 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 9 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 19 Sep 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?
Change in Sleep Efficiency (time frame: Baseline, 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318131, which also lists 1 linked publication.
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 19 Sep 2024.