Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

NCT05318131 | Completed

• 1 other identifier: 20-00078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

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

  Baseline, 3 months

• Change in device-based step counts per day

  Baseline, 3 months

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

  Baseline, 3 months

• Change in Dietary Consumption

  Baseline, 3 months

Study Arms (1)

Single Arm Prospective Study

EXPERIMENTAL

Other: Sleep and Lifestyle Advice Website; Other: Surveys and Sleep Monitors

Interventions

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.

Single Arm Prospective Study

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.

Single Arm Prospective Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• New York State Department of Health: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 39416756 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sleep; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stacy Loeb, MD MSc

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: August 30, 2022
• Primary Completion: September 26, 2023
• Study Completion: October 12, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request for the purposes of an IRB approved scientific research project. Requests should be directed to stacy.loeb@nyulangone.org. To gain access, data requestors will need an IRB approved protocol and to sign a data access agreement.

Locations

US (1)