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OpenTrials
Completed

NCT Number: NCT05318131

Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep and Lifestyle Advice Website

Other

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 Monitors

Other

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 outcomes

  1. 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).

  2. 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).

  3. Change in Sleep Duration

    Time frame: Baseline, 3 months

    The study team will use ActiGraph software to calculate device-based measures of sleep duration

  4. 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.

  5. 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.

  6. 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)

Secondary outcomes

  1. Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day

    Time frame: Baseline, 3 months

    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.

  2. Change in device-based step counts per day

    Time frame: Baseline, 3 months

    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.

  3. Change in self-reported total physical activity MET-minutes per day

    Time frame: Baseline, 3 months

    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.

  4. Change in Dietary Consumption

    Time frame: Baseline, 3 months

    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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • New York State Department of Health

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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