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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR003098 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism.
The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted eating | Experimental | Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship. |
|
| Control | Other | Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-restricted eating | Behavioral | 12 weeks of time-restricted eating (10-hour window) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study | To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed. | 12 weeks |
| Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire | FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40186671 | Derived | Kleckner AS, Clingan CL, Youngblood SM, Kleckner IR, Quick L, Elrod RD, Zhu S, Manoogian ENC, Panda S, Badros AZ, Emadi A. Time-restricted eating to address persistent cancer-related fatigue among cancer survivors: a randomized controlled trial. Support Care Cancer. 2025 Apr 5;33(4):353. doi: 10.1007/s00520-025-09394-w. |
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Participants must have completed baseline assessments, including the FACIT-F questionnaire, in order to be randomized. There were 20 people who consented to the study but did not complete baseline assessments and therefore were not randomized to an arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Time-restricted Eating | Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship. Time-restricted eating: 12 weeks of time-restricted eating (10-hour window) Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
| FG001 | Control | Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship. Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Time-restricted Eating | Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship. Time-restricted eating: 12 weeks of time-restricted eating (10-hour window) Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
| 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 | Feasibility, as Assessed by the Percentage of Participants Who Enrolled Completed the Study | To assess feasibility, the percentage of participants who provide evaluable data regarding their eating window at baseline and 12 weeks will be assessed. | Posted | Count of Participants | Participants | 12 weeks |
|
|
13 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 self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times). Participants will also receive weekly tips to encourage a healthy lifestyle in cancer survivorship. Time-restricted eating: 12 weeks of time-restricted eating (10-hour window) Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Kleckner, PhD | University of Maryland School of Nursing | 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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 28, 2022 | Apr 17, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
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| Healthy lifestyle education | Behavioral | Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
|
| BG001 | Control | Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship. Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| 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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| Primary | Fatigue, as Assessed Using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Questionnaire | FACIT-F fatigue subscale scores will be compared for those in the time-restricted eating group vs. the control group at week 12, controlling for baseline levels. This questionnaire is 13-items long. The scale is from 0-52, and a higher score indicates less fatigue. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Control | Participants will receive weekly tips to encourage healthy lifestyle behaviors in cancer survivorship. Healthy lifestyle education: Weekly tips on healthy lifestyle behaviors (e.g., diet, exercise, sleep) for 12 weeks | 0 | 15 | 2 | 15 | 0 | 15 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D001519 | Behavior |