Prolonged Nightly Fasting in Breast Cancer Survivors

Change in body mass index (BMI) (kg/m^2)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (kg/m\^2). Body mass index calculated using patient height (meters) and weight (kilograms) measured at baseline and at the completion of the study intervention. BMI = weight in kilograms divided by the square of height in meters.

Time frame: 12 weeks

Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)

FACT-G is a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)

Time frame: 6 and 12 weeks

Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)

Effects of prolonged nightly fasting on psychological well-being using The Hospital Anxiety and Depression Scale (HADS). Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)

Time frame: 6 and 12 weeks

Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue

13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent better functioning or less fatigue.Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences

Time frame: 6 and 12 weeks

Change in physical activity using the Godin Leisure-Time Exercise Questionnaire

Calculated score where patient-reported weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula: Weekly leisure activity score = (9 x Strenuous) + (5 x Moderate) + (3 x Light)

Time frame: 6 and 12 weeks

Change in lipid profile

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL).

Time frame: 12 weeks

Change in hemoglobin A1c (%)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%)

Time frame: 12 weeks

Change in c-reactive protein (mg/L)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD)

Time frame: 12 weeks

Change in interleukin-6 (pg/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL

Time frame: 12 weeks

Change in tumor necrosis factor alpha (pg/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL

Time frame: 12 weeks

Change in insulin (mcU/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL)

Time frame: 12 weeks

Change in leptin (ng/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)

Time frame: 12 weeks

Change in adiponectin level (microgram/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL)

Time frame: 12 weeks

Change in insulin-like growth factor (ng/mL)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)

Time frame: 12 weeks

Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)

Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL)

Time frame: 12 weeks