Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318131
• Other study ID #: 20-00078
• Status: Completed
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: October 12, 2023

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 12, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Sleep and Lifestyle Advice Website
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
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	New York State Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Sleep Duration	The study team will use ActiGraph software to calculate device-based measures of sleep duration	Baseline, 3 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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