Cancer Survivorship
Conditions
Brief summary
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
Detailed description
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.
Interventions
BEHAVIORALTime-restricted eating
Restrict food and beverage intake (except water) to a 10-hour window
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern | 14 days | Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Time-restricted Eating 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.
Time-restricted eating: Restrict food and beverage intake (except water) to a 10-hour window | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Time-restricted Eating |
|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 2 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
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
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time-restricted Eating | Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern | 90.1 percent of days |