Breast Cancer Survivor, Cancer Related Cognitive Difficulties, Sleep, Quality of Life
Conditions
Keywords
breast cancer, breast cancer survivor, brain fog, prolonged nightly fasting, nationwide, remote, non-invasive, health education, sleep, quality of life
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.
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.
Interventions
BEHAVIORALProlonged 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.
BEHAVIORALHealth 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.
Sponsors
Mayo Clinic
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Statistician will also be masked to condition
Intervention model description
One group will be assigned to Prolonged Nightly Fasting (PNF) and Health Education videos, the other group will be assigned to Health Education videos.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition. | Baseline (T1) and 8-week end point (T2) data collection | The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep using a scale of 0-21 |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Aim: Explore acceptability of the PNF intervention | 8-week end point (T2) data collection | participant adherence to protocol |
| Covariate Measure: eating behaviors | Baseline (T1) and 8-week end point (T2) data collection. | 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 |
Countries
United States
Contacts
Primary ContactJen Project Coordinator
Backup ContactDorothy Sears, PhD
Outcome results
None listed