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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 F

Первичные конечные точки

• Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition. [Срок оценки: 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. [Срок оценки: Baseline (T1) and 8-week end point (T2) data collection]

Вторичные конечные точки (3)

• Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Baseline (T1) and 8-week end point (T2) data collection.]

Критерии участия

Критерии включения

• ≥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

Критерии исключения

• 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

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Arizona State University — Phoenix

Идентификаторы

NCT: NCT06938555 · STUDY00021379

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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