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NCT06938555 | RECRUITING | Breast Cancer Survivor

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

Arizona State University

Information provided by (Responsible Party):

Dorothy Sears

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.

Condition or disease

Breast Cancer Survivor

Cancer Related Cognitive Difficulties

Sleep

Quality of Life

Intervention/treatment

Prolonged Nightly Fasting

Health Education Videos

Phase

NA

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
Estimated Enrollment : 60 participants
Masking : SINGLE
Masking Description : Statistician will also be masked to condition
Primary Purpose : TREATMENT
Official Title : The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors (RESTORE)
Actual Study Start Date : 2025-03-18
Estimated Primary Completion Date : 2026-03-18
Estimated Study Completion Date : 2026-03-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

Location Details

NCT06938555

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How to Participate

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Locations

RECRUITING

United States, Arizona

Arizona State University

Phoenix, Arizona, United States, 85004