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

NCT06938555 | Recruiting

• 1 other identifier: STUDY00021379
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Survivor; Sleep; Cancer Related Cognitive Difficulties; Quality of Life

Keywords

breast cancer; breast cancer survivor; brain fog; prolonged nightly fasting; nationwide; remote; non-invasive; health education; sleep; quality of life

Outcome Measures

Primary Outcomes (2)

• Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.

  The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156

  Baseline (T1) and 8-week end point (T2) data collection

• Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.

  The Montreal Cognitive Assessment (T-MoCA) will be used to assess objective cognitive assessment using a scale of 0-22

  Baseline (T1) and 8-week end point (T2) data collection

Secondary Outcomes (3)

• Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.

  Baseline (T1) and 8-week end point (T2) data collection

• Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.

  Baseline (T1) and 8-week end point (T2) data collection

• Examine PNF-induced changes in quality of life as compared to the HED-Only Control condition.

  Baseline (T1) and 8-week end point (T2) data collection.

Other Outcomes (4)

• Exploratory Aim: Explore acceptability of the PNF intervention

  8-week end point (T2) data collection

• Exploratory Aim: Explore acceptability of the PNF intervention

  8-week end point (T2) data collection

• Exploratory Aim: Explore acceptability of the PNF intervention

  8-week end point (T2) data collection

Study Arms (2)

Prolonged Nightly Fasting and Health Education Videos

EXPERIMENTAL

Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.

Behavioral: Prolonged Nightly Fasting; Behavioral: Health Education Videos

Health Education Videos Only

ACTIVE COMPARATOR

Participants in the Health Education Only condition will participate in only the Health Education Video intervention. Investigators will provide materials about Prolonged Nightly Fasting to these participants at the end of the study.

Behavioral: Health Education Videos

Interventions

Prolonged Nightly Fasting BEHAVIORAL

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.

Prolonged Nightly Fasting and Health Education Videos

Health Education Videos BEHAVIORAL

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.

Health Education Videos Only; Prolonged Nightly Fasting and Health Education Videos

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• diagnosed with breast cancer (all stages included)
• ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
• score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
• able to speak/understand English
• have access to a computer and Wi-Fi
• live within the United States
• Identifies as female
• willing and able to fully participate in the study

You may not qualify if:

• type 1 diabetes
• actively enrolled in formal diet/weight loss program
• previous bariatric surgery
• eating disorder history
• night shift work
• pregnant, breast feeding, or trying to get pregnant
• dementia, psychological, psychiatric, or neurological diagnoses
• active brain or central nervous system disease
• prior or current use of memory enhancing medications
• history or current brain radiation
• frequently fasting for 12+ hours every night
• \) history of hypoglycemia 14) depression screening on PHQ9 with a score of 20 or greater across all 9 questions OR anything other than 0 on question 9

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Mental Fatigue; Health Education

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Dorothy Sears, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Sarah James, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen Project Coordinator

CONTACT

602-496-8248; restorestudy@asu.edu

Dorothy Sears, PhD

CONTACT

602-496-3351; Dorothy.Sears@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Statistician will also be masked to condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director and Professor

Model Details: One group will be assigned to Prolonged Nightly Fasting (PNF) and Health Education videos, the other group will be assigned to Health Education videos.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 22, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)