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

ConditionsBreast Cancer Survivor Cancer Related Cognitive Difficulties Sleep Quality of Life

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorArizona State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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)

Disqualifiers

type 1 diabetes

actively enrolled in formal diet/weight loss program

previous bariatric surgery

eating disorder history

Trial design

Design model

Parallel

Treatments tested in this trial

Prolonged Nightly Fasting
Behavioral
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.
Health Education Videos
Behavioral
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Prolonged Nightly Fasting and Health Education VideosExperimental treatment 2 interventions

Group B: Health Education Videos OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Examine PNF-induced changes in cognitive function as compared to the HED-Only control condition.

The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess subjective cognitive function using a scale of 0-156

Time frame

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.

The Montreal Cognitive Assessment (T-MoCA) will be used to assess objective cognitive assessment using a scale of 0-22

Time frame

Baseline (T1) and 8-week end point (T2) data collection

Secondary outcomes

Examine PNF-induced changes in sleep (i.e., duration, quality) and insomnia as compared to the HED-Only Control condition.

Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep using a scale of 0-21

Time frame

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.

Insomnia Severity Index (ISI) will be used to assess insomnia using a scale of 0-28

Time frame

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.

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.

Time frame

Baseline (T1) and 8-week end point (T2) data collection.

Other outcomes

Exploratory Aim: Explore acceptability of the PNF intervention

participant adherence to protocol

Time frame

8-week end point (T2) data collection

Exploratory Aim: Explore acceptability of the PNF intervention

participant retention

Time frame

8-week end point (T2) data collection

Exploratory Aim: Explore acceptability of the PNF intervention

qualitative interviews

Time frame

8-week end point (T2) data collection

Covariate Measure: eating behaviors

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

Time frame

Baseline (T1) and 8-week end point (T2) data collection.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Mayo Clinic

Collaborator

Source ClinicalTrials.gov

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