Anatomic Stage I Breast Cancer AJCC v8NCT05930483
Remotely Delivered, Community-Aligned Weight Loss Interventions Among Breast Cancer Survivors, ¡Vida! Trial
A study testing ¡Vida! program, ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] and Health Coaching in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- ¡Vida! program, ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] and Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biologically female
- Age >= 18 years
- Self-identifies Hispanic/Latina
- Able to read and write in Spanish and/or English
- Previous diagnosis of stage I-III BC within the past 5 years
- No evidence of current, recurrent, or metastatic disease
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- 60 days post treatment, including chemotherapy, radiation therapy, and cancer-related surgery (NOTE: current allowed therapies include endocrine therapy, CDK4/6 inhibitors (e.g. palbociclib,ribociclib, abemaciclib), HER2-directed therapies (e.g., trastuzumab, neratinib), and monoclonal antibodies (e.g., pertuzumab, pembrolizumab); surgery for breast reconstruction is allowed during the trial)
- Body mass index (BMI) >= 27 kg/m^2 initially assessed via self-reported height and weight and confirmed prior to randomization via a tape measure and Bluetooth-enabled scale
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Willingness to participate in all study activities
- Access to phone for study contacts
- Access to internet to participate in the online program and to be able to sync study devices
- Successful completion of at-home baseline assessments prior to randomization
Who cannot join
- Body mass index (BMI) < 27 kg/m^2 at time of baseline data collection
- Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
- Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
- Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine [T-DM1], trastuzumab deruxtecan [T-DXd])
- Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
- Pregnant, breastfeeding, or planning to become pregnant during the study period
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- Use of exogenous hormones for gender affirmation
- For stool sample collection only: Self-reported use of oral or intravenous antibiotics, antifungals, or anti-parasitics during the past 6 months
- For stool sample collection only: Presence of self-reported ileostomy or colostomy
- For stool sample collection only: Presence of self-reported inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis)
- Anticipated major surgical procedure (e.g., hysterectomy) within 3 months after study registration. Breast reconstruction is allowed during study participation.
- Concurrent enrollment in another weight loss or physical activity trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jenny Whitten-Brannon, 206-667-5625, jwhitten@fredhutch.org
Heather Greenlee
About this study
Official title: Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
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.
Read the detailed description
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).
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- ¡Vida! program, ¡Vida! Plus [¡Vida! + Experiential Learning (EL)], Health Coaching, Mailed Toolkits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¡Vida! programBehavioural
Also called Behavioral Intervention
Participate in ¡Vida! program
¡Vida! Plus [¡Vida! + Experiential Learning (EL)]Behavioural
Participate in ¡Vida! Plus program
Health CoachingBehavioural
Receive health coaching
Mailed ToolkitsBehavioural
Receive a mailed toolkit of health items
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ¡Vida! program |
| 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). Receives: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] |
| 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. Receives: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Behavioral: Health Coaching |
| 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. Receives: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] |
| 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. Receives: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Behavioral: Health Coaching |
| 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). Receives: Behavioral: ¡Vida! program; Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]; Behavioral: Health Coaching; Behavioral: Mailed Toolkits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (1)
Body weight (kg) percent change as moderated by baseline characteristics
Will be determined by whether EAI effectiveness is moderated by baseline patient characteristics.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start8 Apr 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heather Greenlee, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930483
- Sponsor's protocol ID
- RG1123416
- Other IDs
- NCI-2023-03748, 0020054, R01CA270441
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a SMART Design to Evaluate Remotely Delivered, Community-aligned Weight Loss Interventions Among Breast Cancer Survivors: The ¡Vida! Study
- ClinicalTrials.gov ID
- NCT05930483
- Acronym / sponsor ID
- RG1123416
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida! | Experimental | Behavioral: ¡Vida! programParticipants 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. |
| Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus | Experimental | Behavioral: ¡Vida! program, Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]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). |
| Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) | Experimental | Behavioral: ¡Vida! program, Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)], Behavioral: Health CoachingParticipants 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. |
| Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus | Experimental | Behavioral: ¡Vida! program, Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]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. |
| Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC) | Experimental | Behavioral: ¡Vida! program, Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)], Behavioral: Health CoachingParticipants 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. |
| Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits | Experimental | Behavioral: ¡Vida! program, Behavioral: ¡Vida! Plus [¡Vida! + Experiential Learning (EL)], Behavioral: Health Coaching, Behavioral: Mailed ToolkitsParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Biologically female
- Age >= 18 years
- Self-identifies Hispanic/Latina
- Able to read and write in Spanish and/or English
- Previous diagnosis of stage I-III BC within the past 5 years
Key exclusion criteria (12 listed)
- Body mass index (BMI) < 27 kg/m^2 at time of baseline data collection
- Diabetic with current use of insulin or sulfonylurea medications (note: current use of metformin is allowed)
- Use of glucagon-like peptide-1 (GLP1) receptor agonist medications reported at baseline
- Current use of cytotoxic chemotherapy medications (e.g., capecitabine) or drug-antibody conjugates (e.g., trastuzumab emtansine [T-DM1], trastuzumab deruxtecan [T-DXd])
- Major comorbidities or physical limitations that would preclude from healthy weight loss, reducing energy intake or engaging in PA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ¡Vida! programAlso: Behavioral InterventionParticipate in ¡Vida! program | Behavioural | Arm A - Stage 1: ¡Vida!; Stage 2: ¡Vida!, Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus, Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus, Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits |
| ¡Vida! Plus [¡Vida! + Experiential Learning (EL)]Participate in ¡Vida! Plus program | Behavioural | Arm B - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus, Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm D - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus, Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits |
| Health CoachingReceive health coaching | Behavioural | Arm C - Stage 1: ¡Vida!; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm E - Stage 1: ¡Vida! + ¡Vida! Plus; Stage 2: ¡Vida! + ¡Vida! Plus + Health Coaching (HC), Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits |
| Mailed ToolkitsReceive a mailed toolkit of health items | Behavioural | Arm F-Stage 1:¡Vida! + ¡Vida! Plus; Stage 2:¡Vida! + ¡Vida! Plus + Health Coaching + Mailed Toolkits |
Primary outcome
Body weight (kg) percent change
Time frame: Baseline to 12 months
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.
1 secondary outcome
Body weight (kg) percent change as moderated by baseline characteristics
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Greenlee principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ¡Vida! program, ¡Vida! Plus [¡Vida! + Experiential Learning (EL)] and Health Coaching in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Whitten-Brannon (206-667-5625, jwhitten@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (kg) percent change (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.