Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study

Study Overview
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Brief Summary
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The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.

Detailed Description
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In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.

Official Title
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Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study

Conditions
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Cancer Survivorship

Intervention / Treatment
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* Behavioral: Time-restricted eating


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Participants must...) Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling, Have a baseline level of fatigue, as determined by reporting a score of 3 or higher for the question, In the last week, how bad was your worst fatigue on a scale from 0-10? Be able to speak English, Be at least 18 years old, Be willing and able to adhere to study procedures, and Be able to provide written informed consent. Exclusion Criteria (Participants must not...): Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week, Be underweight, as defined as a body mass index ≤20.0 kg/m2. Not have surgery planned in the next month, Not have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder), Not be taking insulin, or Be on enteral or parenteral nutrition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-restricted eating<br>Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. | Behavioral: Time-restricted eating<br>* Restrict food and beverage intake (except water) to a 10-hour window<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern | Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern | 14 days |