Clinical trial · Interventional
Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer
NCT05318131CI-TRIAL-00080828completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sleep and Lifestyle Advice Website | Other | — | UNRESOLVED |
| Surveys and Sleep Monitors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm Prospective Study
- interventionNames
- Other: Sleep and Lifestyle Advice Website
- Other: Surveys and Sleep Monitors
Primary outcomes (6)
- measure
- Change in Sleep Efficiency
- timeFrame
- Baseline, 3 months
- description
- 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).
- measure
- Change in Number of Awakenings After Sleep Onset
- timeFrame
- Baseline, 3 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTLoeb 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