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

Arizona State University (ASU)

Status: Enrolling

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

Treatments: Behavioral: Health Education Videos; Behavioral: Prolonged Nightly Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT06938555

STUDY00021379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Prolonged Nightly Fasting and Health Education Videos

Experimental group

Description:

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

Treatment:

Behavioral: Health Education Videos

Behavioral: Prolonged Nightly Fasting

Health Education Videos Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education Videos