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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-03748 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0020054 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA270441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates remotely delivered, community-aligned weight loss interventions in Latina breast cancer survivors. Breast cancer is the second leading cause of cancer death among women in the US. There are population differences in breast cancer mortality, based on specific risk factors, including obesity. Cancer is the leading cause of death among Latinos, and among Latinas, breast cancer is the leading cause of cancer death. An estimated 80% of Latinas in the United States have overweight/obesity, which is associated with poorer breast cancer outcomes. However, few, if any, effective interventions exist to promote and maintain weight loss in Latina breast cancer survivors. The development of an adaptive program that provides survivors with the support they need, as opposed to what is typically available, to improve breast cancer survivorship.
OUTLINE: This sequential multiple assignment randomized trial (SMART) will test four different community-aligned 12-month adaptive weight loss interventions.
BASELINE: Participants receive written instructions and website link to complete surveys along with supportive materials including a measuring tape, Bluetooth-enabled scale, and may receive an Actigraph accelerometer to be worn for 7 days at baseline. Participants also undergo blood sample collection at baseline.
STAGE ONE: Eligible participants from the baseline run-in are randomized to participate in Stage One. In Stage One, participants are randomized to one of two groups: ¡Vida! or ¡Vida! Plus.
STAGE TWO: Percent weight loss is measured at week 8. Women who lose ≥2% of their body weight at week 8 will be considered "Responders" and will continue with their original randomization assignment in Stage Two.
Women in the Stage One ¡Vida! group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus or ¡Vida! Plus + health coaching (HC). Women in the Stage One ¡Vida! Plus group who lose <2% of their body weight will be re-randomized in Stage Two to receive either ¡Vida! Plus + HC or ¡Vida! Plus + HC + mailed toolkits (MT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida! | Experimental | Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! intervention programming. |
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| Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus | Experimental | Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL). |
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| Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) | Experimental | Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive ¡Vida! Plus programming: the ¡Vida! Program plus Experiential Learning (EL), and also receive health coaching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ¡Vida! program | Behavioral | Participate in ¡Vida! program |
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| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) percent change | Will be assessed by the percent of weight loss at month 12 and compared across the four embedded adaptive intervention (EAI) groups using the doubly robust estimator model. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) percent change as moderated by baseline characteristics | Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Whitten-Brannon | Contact | 206-667-5625 | jwhitten@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Recruiting | Seattle | Washington | 98109 | United States |
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| Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus | Experimental | Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were responders (≥2% weight loss at 8 weeks). In Stage 2, responders receive additional ¡Vida! Plus intervention programming. |
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| Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) | Experimental | Participants participate in the online ¡Vida! program consisting of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching. |
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| Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits | Experimental | Participants participate in the online ¡Vida! program of 25 health education online sessions, dietary modifications, and home-based exercise sessions on study. Participants receive supportive materials consisting of a Bluetooth-enabled scale, a Fitbit Charge 6 (or latest device), the Fitbit application (app), and access to the Cook for Your Life website on study. Participants also receive Experiential Learning (EL) by attending 14 remote lifestyle health education sessions. Participants also receive 9 30-minute individualized telephone health coaching sessions, and receive a mailed toolkit of health items twice on study. Participants also undergo blood sample collection on study. This arm includes participants who were randomized to ¡Vida! + ¡Vida! Plus in Stage 1 and were non-responders (<2% weight loss at 8 weeks). In Stage 2, non-responders receive additional ¡Vida! Plus intervention programming, and also receive health coaching (HC) as well as mailed toolkits (MT). |
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| ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] | Behavioral | Participate in ¡Vida! Plus program |
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| Health Coaching | Behavioral | Receive health coaching |
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| Mailed Toolkits | Behavioral | Receive a mailed toolkit of health items |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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