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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Sleep; Breast Cancer Survivor; Cancer Related Cognitive Difficulties
• Intervention / Treatment: Behavioral: Prolonged Nightly Fasting; Behavioral: Health Education Videos

Detailed Description

The purpose of this innovative, remotely-delivered pilot randomized controlled trial (RCT) is to explore the use of an 8-week prolonged nightly fasting (PNF) intervention, as compared to a Health Education-Only (HED-Only) control condition, among ethnically and racially diverse (≥50% Black, Hispanic, and/or Native American) breast cancer survivors (BCSs) with cancer-related cognitive impairment (CRCI) to examine changes in cognitive function, sleep, insomnia and health-related quality of life (i.e., mental and physical). Additionally, intervention feasibility will be assessed among the PNF participants. All participants will receive health education (HED) throughout. BCSs living with CRCI (N=60) will be recruited nationwide and randomized 1:1 into the PNF or HED-Only groups. Linear mixed models will be used to compare outcome changes in the PNF group compared to HED-Only group (Aims 1-3); descriptive and qualitative analyses will be used in the Exploratory Aim.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorothy Sears, PhD; Phone Number: 602-496-3351; Email: Dorothy.Sears@asu.edu
• Study Contact Backup: Name: Jen Project Coordinator; Phone Number: 602-496-8248; Email: restorestudy@asu.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Arizona State University
      • Contact: Dorothy Sears, PhD; Phone Number: 602-496-3351; Email: Dorothy.Sears@asu.edu
      • Principal Investigator: Dorothy Sears, PhD
      • Contact: Jen Project Coordinator; Phone Number: 602-496-8248; Email: restorestudy@asu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥18 years old
2. diagnosed with breast cancer (all stages included)
3. ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
4. score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
5. able to speak/understand English
6. have access to a computer and Wi-Fi
7. live within the United States
8. Identifies as female
9. willing and able to fully participate in the study

Exclusion Criteria:

1. type 1 diabetes
2. actively enrolled in formal diet/weight loss program
3. previous bariatric surgery
4. eating disorder history
5. night shift work
6. pregnant, breast feeding, or trying to get pregnant
7. dementia, psychological, psychiatric, or neurological diagnoses
8. active brain or central nervous system disease
9. prior or current use of memory enhancing medications
10. history or current brain radiation
11. frequently fasting for 12+ hours every night

13) 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolonged Nightly Fasting and Health Education Videos; Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions.	Behavioral: Prolonged 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.; Behavioral: Health 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.
Active Comparator: Health Education Videos Only; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.	Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep using a scale of 0-21	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.	Insomnia Severity Index (ISI) will be used to assess insomnia using a scale of 0-28	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.	Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS Global-10) questionnaire will be used to measure health-related quality of life (i.e., mental health, physical health). It uses a scale of 0-20.	Baseline (T1) and 8-week end point (T2) data collection.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Aim: Explore acceptability of the PNF intervention	participant adherence to protocol	8-week end point (T2) data collection
Exploratory Aim: Explore acceptability of the PNF intervention	participant retention	8-week end point (T2) data collection
Exploratory Aim: Explore acceptability of the PNF intervention	qualitative interviews	8-week end point (T2) data collection
Covariate Measure: eating behaviors	Rapid Eating Assessment for Participants -- Shortened Version (REAPS) will be used to assess food intake quantity and quality changes. This uses a scale of 13-39	Baseline (T1) and 8-week end point (T2) data collection.

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Dorothy Sears, PhD, Arizona State University; Principal Investigator: Sarah James, MD, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; sleep; quality of life; non-invasive; health education; nationwide; breast cancer survivor; brain fog; remote; prolonged nightly fasting
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Skin Diseases; Breast Diseases; Fatigue; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Adherence Interventions; Medication Adherence; Breast Neoplasms; Mental Fatigue; Health Education
• Other Study ID Numbers: STUDY00021379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Protocol and consent state, "De-identified data collected as a part of this study will not be shared with other investigators or industry partners for future research purposes."

This is a pilot study and only aggregated data may be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No