Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

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

Detailed Description
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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.

Official Title
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Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Sleep and Lifestyle Advice Website
* Other: Surveys and Sleep Monitors


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm Prospective Study<br> | Other: Sleep and Lifestyle Advice Website<br>* 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.<br>Other: Surveys and Sleep Monitors<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | Baseline, 3 months | 
| Change in Sleep Duration | The study team will use ActiGraph software to calculate device-based measures of sleep duration | 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. | 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. | 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) | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | Baseline, 3 months |