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Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep and Lifestyle Advice Website
Surveys and Sleep Monitors
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Adult U.S. male age >18 with prostate cancer OR
  2. Adult U.S. male or female >18 who is a family member/partner/caregiver of a prostate cancer patient AND
  3. Telephone and internet access AND
  4. Able to read, comprehend, and sign informed consent in English AND
  5. Perceived deficits in sleep, nutrition, and/or physical activity

Exclusion Criteria:

  1. Age <18 years
  2. Not English proficient
  3. No or irregular access to the same telephone number and/or mailing address
  4. No or less than weekly access to the internet
  5. Patients who do not have a diagnosis of prostate cancer
  6. Caregivers/family members for a condition other than prostate cancer
  7. Mental or cognitive impairment that interferes with ability to provide informed consent
  8. Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate)
  9. Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Prospective Study

Arm Description

Outcomes

Primary Outcome Measures

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).
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).
Change in Sleep Duration
The study team will use ActiGraph software to calculate device-based measures of sleep duration
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.
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.
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)

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
March 23, 2022
Last Updated
June 13, 2023
Sponsor
NYU Langone Health
Collaborators
New York State Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05318131
Brief Title
Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
Official Title
Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
New York State Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Prospective Study
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Sleep and Lifestyle Advice Website
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Surveys and Sleep Monitors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sleep Efficiency
Description
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).
Time Frame
Baseline, 3 months
Title
Change in Number of Awakenings After Sleep Onset
Description
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).
Time Frame
Baseline, 3 months
Title
Change in Sleep Duration
Description
The study team will use ActiGraph software to calculate device-based measures of sleep duration
Time Frame
Baseline, 3 months
Title
Change in Sleep Hygiene Index (SHI) Score
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Insomnia Severity Index Score
Description
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)
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day
Description
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.
Time Frame
Baseline, 3 months
Title
Change in device-based step counts per day
Description
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.
Time Frame
Baseline, 3 months
Title
Change in self-reported total physical activity MET-minutes per day
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Dietary Consumption
Description
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).
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Loeb, MD MSc
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to the data upon reasonable request for the purposes of an IRB approved scientific research project. Requests should be directed to stacy.loeb@nyulangone.org. To gain access, data requestors will need an IRB approved protocol and to sign a data access agreement.

Learn more about this trial

Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

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