This clinical trial examines the sleep and lifestyle habits of men with prostate cancer, and whether a website with sleep and lifestyle recommendations leads to improvements in sleep and lifestyle habits. Poor sleep is a common side effect of prostate cancer and prostate cancer treatment. Poor sleep health is associated with poor mental health, and more medical visits and hospitalizations. Information gained from this trial may help researchers better understand sleep and lifestyle issues in prostate cancer patients, and how to improve quality of life for future patients and caregivers.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05318131.
PRIMARY OBJECTIVES:
I. To examine the impact of prostate cancer on sleep for patients and caregivers, and to examine the proportion of providers who address sleep issues in prostate cancer. (Phase 1 [online survey])
II. To determine whether exposure to a website with assessment questions and tailored recommendations about sleep and lifestyle for prostate cancer patients and caregivers leads to an improvement in sleep quality based on objective (actigraphy) or subjective (questionnaire) measures. (Phase 2 [prospective study with actigraphy])
SECONDARY OBJECTIVES:
I. Assessing the relationship between sleep with exercise, depression, cognitive impairment and quality of life. (Patient and caregiver portion) (Phase 1 [online survey])
II. To determine whether exposure to the website leads to increases in physical activity and cruciferous vegetable and tomato intake; decreases in consumption of saturated fat, whole dairy and processed meat; as well as preparatory measures (e.g., making an appointment with a healthcare provider for sleep evaluation, joining a fitness program). (Phase 2 [prospective study with actigraphy])
OUTLINE:
PHASE I: Patients and caregivers complete an online survey over 10-15 minutes assessing sleep and exercise habits among prostate cancer patients and caregivers, and survivorship recommendations related to sleep and exercise among prostate cancer providers.
PHASE II: Participants complete surveys over 30 minutes assessing sleep and exercise habits at baseline and 3 months (after website access), and then receive access to view a website with advice about sleep and lifestyle for prostate cancer patients and caregivers for 3 months. Participants also receive a phone call at 6 weeks from study team to discuss their progress and provide tailored recommendations. Participants wear an actigraph on their wrist for 1 week at baseline (before website access) and for 1 week at 3 months (after website access). At the end of the week, participants participate in an interview over 30 minutes to provide feedback about the website.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorStacy Loeb
