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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07643 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10335 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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The purpose of this phase II trial is to identify the most effective dose level (number of classes) of a diet and physical activity lifestyle program based on how well it improves diet and physical activity in stage 0-III breast cancer survivors. Study results may provide researchers with information on how to best implement diet and physical activity recommendations among breast cancer survivors.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM A (LOW DOSE): Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
ARM B (HIGH DOSE): Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (low dose nutrition and PA class, eHealth intervention) | Active Comparator | Participants attend one diet and physical activity class delivered remotely via Zoom and receive an eHealth communication intervention for 6 months. |
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| Arm B (high dose nutrition and PA class, eHealth intervention) | Experimental | Participants attend 12 twice monthly diet and physical activity online sessions delivered remotely via Zoom and receive an eHealth communication intervention for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One Diet and Physical Activity Session | Behavioral | Attend 1 remote diet and physical activity session |
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| Measure | Description | Time Frame |
|---|---|---|
| Accrual rate | Accrual rate will be measured by number of participants randomized during each month of study accrual. | At 6 months |
| Adherence: Session(s) Attendance | Adherence will be measured by number of online session(s) attended per participant. | At 6 months |
| Adherence: Responsiveness to eHealth communication | Adherence will be measured by the number of responses to text messages per participant. | At 6 months |
| Biospecimen collection rate | Biospecimen collection rate will be assessed based on number of biospecimens collected. | At 6 months |
| Retention | Retention will be measured by the number of completed study assessments per participants. | At 6 months |
| Acceptability: Questions during exit interview | Acceptability will be measured by questions asking about trial acceptability in the exit questionnaire. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in daily servings of fruits and vegetables per day | Will be assessed by 24-hour dietary recalls. | Baseline to 6 months |
| Change in minutes per week of moderate-to-vigorous physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy E Davidson | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Heather Greenlee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36336249 | Derived | Ueland K, Sanchez SC, Rillamas-Sun E, Shen H, Schattenkerk L, Garcia G, VanDoren M, Myers SA, Santiago-Torres M, Di C, Dey N, Guthrie KA, Yung R, Davidson NE, Greenlee H. A digital health intervention to improve nutrition and physical activity in breast cancer survivors: Rationale and design of the Cook and Move for Your Life pilot and feasibility randomized controlled trial. Contemp Clin Trials. 2022 Dec;123:106993. doi: 10.1016/j.cct.2022.106993. Epub 2022 Nov 3. | |
| 35788100 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2020 | Apr 8, 2021 |
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|
| Electronic (e) Health (eHealth) Communication Intervention | Other | Receive eHealth communication intervention |
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| Twelve Diet and Physical Activity Group Sessions | Behavioral | Attend 12 remote diet and physical activity sessions in 6 months |
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| Questionnaire Administration | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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Will be assessed by 7-day accelerometer data.
| Baseline to 6 months |
| Change in systemic inflammation | Will be assessed by fasting blood concentrations of high sensitivity C-reactive protein. | Baseline to 6 months |
| Change in gut barrier permeability | Will be assessed by fasting circulating levels of gut bacterial endotoxin liposaccharide-binding protein. | Baseline to 6 months |
| Derived |
| Rillamas-Sun E, Schattenkerk L, Cobos S, Ueland K, Gaffney AO, Greenlee H. Characteristics of Users of the Cook for Your Life Website, an Online Nutrition Resource for Persons Affected by Cancer: Descriptive Study. JMIR Cancer. 2022 Jul 5;8(3):e37212. doi: 10.2196/37212. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D006262 | Health |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011154 | Population Characteristics |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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