Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Sleep and Lifestyle Advice WebsiteOther: Surveys and Sleep Monitors
- Registration Number
- NCT05318131
- Lead Sponsor
- NYU Langone Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Prospective Study Sleep and Lifestyle Advice Website - Single Arm Prospective Study Surveys and Sleep Monitors -
- Primary Outcome Measures
Name Time Method Change in Number of Awakenings After Sleep Onset 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 Hygiene Index (SHI) Score 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 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 Sleep Efficiency 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 Insomnia Severity Index Score 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)
Change in Sleep Duration Baseline, 3 months The study team will use ActiGraph software to calculate device-based measures of sleep duration
- Secondary Outcome Measures
Name Time Method Change in Dietary Consumption 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).
Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day 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.
Change in device-based step counts per day 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.
Change in self-reported total physical activity MET-minutes per day 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.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States