Clinical trial NCT05318131: Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
Official title: Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York State Department of Health
First posted: 2022-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Sleep Efficiency
timeFrame: Baseline, 3 months
measure: Change in Number of Awakenings After Sleep Onset
timeFrame: Baseline, 3 months
measure: Change in Sleep Duration
timeFrame: Baseline, 3 months
measure: Change in Sleep Hygiene Index (SHI) Score
timeFrame: Baseline, 3 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline, 3 months
measure: Change in Insomnia Severity Index Score
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in device-based moderate-vigorous intensity physical activity (MVPA) minutes per day
timeFrame: Baseline, 3 months
measure: Change in device-based step counts per day
timeFrame: Baseline, 3 months
measure: Change in self-reported total physical activity MET-minutes per day
timeFrame: Baseline, 3 months
measure: Change in Dietary Consumption
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stacy Loeb, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loeb S, Robbins R, Sanchez-Nolasco T, Byrne N, Ruan A, Rivera A, Gupta N, Kenfield SA, Chan JM, Van Blarigan EL, Carter P, Jean-Louis G, Orstad SL. Sleep and health improvement programme (SHIP) for patients with prostate cancer and caregivers. BJUI Compass. 2024 Aug 31;5(10):976-985. doi: 10.1002/bco2.435. eCollection 2024 Oct.