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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Nightly Fasting and Health Education Videos | Experimental | Participants in the Prolonge + HED condition will receive both the Prolonged Nightly Fasting and the Health Education Video interventions. |
|
| Health Education Videos Only | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline (T1) and 8-week end point (T2) data collection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Aim: Explore acceptability of the PNF intervention | participant adherence to protocol | 8-week end point (T2) data collection |
| Exploratory Aim: Explore acceptability of the PNF intervention |
Inclusion Criteria:
Exclusion Criteria:
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
Participants must identify as women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jen Project Coordinator | Contact | 602-496-8248 | restorestudy@asu.edu | |
| Dorothy Sears, PhD | Contact | 602-496-3351 | Dorothy.Sears@asu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dorothy Sears, PhD | Arizona State University | Principal Investigator |
| Sarah James, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Recruiting | Phoenix | Arizona | 85004 | United States |
Protocol and consent state, "De-identified data collected as a part of this study will not be shared with other investigators or industry partners for future research purposes."
This is a pilot study and only aggregated data may be shared.
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One group will be assigned to Prolonged Nightly Fasting (PNF) and Health Education videos, the other group will be assigned to Health Education videos.
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Statistician will also be masked to condition
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| 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. |
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Insomnia Severity Index (ISI) will be used to assess insomnia using a scale of 0-28 |
| 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. | Baseline (T1) and 8-week end point (T2) data collection. |
participant retention
| 8-week end point (T2) data collection |
| Exploratory Aim: Explore acceptability of the PNF intervention | qualitative interviews | 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 | Baseline (T1) and 8-week end point (T2) data collection. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005222 | Mental Fatigue |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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