Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

NCT ID: NCT05318131

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-30
• Study Completion Date: 2023-10-12

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm Prospective Study

Group Type: EXPERIMENTAL

Sleep and Lifestyle Advice Website

Intervention Type: 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.

Surveys and Sleep Monitors

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York State Department of Health

OTHER_GOV

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacy Loeb, MD MSc

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 39416756 (View on PubMed)

Other Identifiers

20-00078

Identifier Type: -

Identifier Source: org_study_id