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The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating | Behavioral | Restrict food and beverage intake (except water) to a 10-hour window |
|
| 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 |
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Inclusion Criteria (Participants must...)
Exclusion Criteria (Participants must not...):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmot Cancer Institute | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36131848 | Derived | Kleckner AS, Altman BJ, Reschke JE, Kleckner IR, Culakova E, Dunne RF, Mustian KM, Peppone LJ. Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. J Integr Oncol. 2022;11(5):379. Epub 2022 May 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | percent of days | 14 days |
|
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Kleckner | University of Maryland Baltimore | 410-706-5961 | amber.kleckner@umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Jun 29, 2022 | Prot_SAP_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 2 |
| 39 |
| insomnia | General disorders | Non-systematic Assessment |
|
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