RecruitingNot ApplicableNCT06938555

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)


Sponsor

Arizona State University

Enrollment

60 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether extending the overnight fasting period (going longer without eating at night) can help improve sleep quality and thinking/memory problems in breast cancer survivors. Many breast cancer survivors experience cognitive difficulties — sometimes called 'chemo brain' — and poor sleep after treatment. This is an online study for women in the United States. **You may be eligible if...** - You are a woman 18 or older who has been diagnosed with breast cancer - You are at least 3 months past completing chemotherapy - You are experiencing self-reported cognitive difficulties - You have access to a computer and Wi-Fi and live in the United States - You do not already fast for 12 or more hours every night **You may NOT be eligible if...** - You have type 1 diabetes or a history of low blood sugar - You have a history of eating disorders - You are pregnant, breastfeeding, or trying to become pregnant - You work night shifts - You have a diagnosis of dementia, serious psychiatric illness, or brain/CNS disease - You have severe depression (PHQ-9 score of 20 or higher, or any suicidal ideation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALProlonged Nightly Fasting

At the start of the intervention (week 1) PNF participants will be asked to engage in fasting (14 hours a night, starting no later than 8pm) six nights a week (for the 8-week study duration). Participants will be asked to track their fasting start/stop times on a tracking sheet provided by study staff. During the nightly fast, participants will be allowed to drink water, coffee or tea (without dairy or sweeteners). Study staff will meet with participants via phone for weekly check-in calls (\~10-15 mins) to collect weekly fasting start/stop dates/times (entered into REDCap); alternately, participants may elect to email or text their fasting start/stop date/times to the study staff.

BEHAVIORALHealth Education Videos

Provision of HED is a retention strategy and can influence outcomes. Thus, all participants will receive HED. Each week, participants will receive hyperlinks to videos focused on health educational content unrelated to fasting, diet and outcome measures. Participants will be asked to view the videos (\~10-15 min) prior to their weekly check-in calls with the study staff (\~5-10 mins for HED-Only Control group). They will receive each week's videos on a Monday, and receive a reminder to view on Friday. Study staff will follow a scripted HED weekly check-in call to ensure consistency of data collected. Weekly topics are as follows: W1: Internet safety, W2: Sun safety, W3: Home safety, W4: Driving safety, W5: Hydration, W6: Dental health, W7: Working environment, W8: Communication. Data collected on electronic forms during all participant/staff check-in calls will be stored in participant-specific ASU Dropbox files.


Locations(1)

Arizona State University

Phoenix, Arizona, United States

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NCT06938555


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