Breast CancerNCT04321135
Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
A study testing Guided Lifestyle Program Intervention in people with Breast Cancer and Gynecologic Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Guided Lifestyle Program Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Self-identify as Hispanic or Latina
- Female
- Stage 0 -III Breast and Gynecological cancer survivors
- Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
- Age >18 at time of diagnosis
- BMI at least 25 kg/m2 BMI between 25 and 55 - chosen because this will include only those participants who are overweight and would not be harmed by a 5% weight loss
Who cannot join
- Plans to move from the community during the study
- A medical condition limiting adherence to diet or physical activity components
- History of significant mental illness
- Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
- Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
This study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with Hispanic/Latina BC \& GC survivors. It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life.
Read the detailed description
Aim 1. To adapt the Moving Forward weight loss intervention for overweight/obese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee.
Aim 2. To conduct a randomized pilot with 40 overweight/obese Hispanic BCS to establish the feasibility of the adapted Moving Forward program based on recruitment, adherence, retention and efficacy.
Aim 3. To explore the effects of the adapted Moving Forward program (Avanzando Juntas) on anthropometric (weight, % body fat, lean mass), behavioral (dietary intake, physical activity) psychosocial (quality of life) and biological (cholesterol, hemoglobin A1c, adiponectin, leptin, inflammation, insulin resistance) outcomes.
Hypothesis: Women in the weight loss program will exhibit improvements in outcomes compared to women in the wait list control group.
Avanzando Juntas supports BC \& GC survivors in adopting physical activity and eating patterns to promote weight loss, bolster QOL and reduce the risk for comorbidities and, potentially, BC \& GC recurrence. A strong, multidisciplinary study team provides expertise in culturally competent programs for Hispanic BCS, cognitive behavioral lifestyle interventions, body composition, breast cancer and program adaptation.
This study is novel in its focus on weight loss among Hispanic BCS and the incorporation of anthropometric, behavioral, biological and psychosocial outcomes. An additional strength is the foundation of community partnerships that will support the current study's efforts, as well as those for a larger trial, and, if successful, the dissemination of the program.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Guided Lifestyle Program Intervention, Self-Guided Lifestyle Program (Control Arm)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Lifestyle Program InterventionBehavioural
The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
Self-Guided Lifestyle Program (Control Arm)Behavioural
In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging
| Study group | Role | What they receive |
|---|---|---|
| Guided Lifestyle Program | Experimental | The Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study. Receives: Behavioral: Guided Lifestyle Program Intervention |
| Self-Guided Lifestyle Program | Active comparator | In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in. Receives: Behavioral: Self-Guided Lifestyle Program (Control Arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable
Measured: Baseline to 4 month
Change in intake of fruits and vegetables
ASA24 dietary analysis of self reported food consumption
Measured: Baseline to 4 month
Change of intake of red meat/processed meat
ASA24 dietary analysis of self reported food consumption
Measured: Baseline to 4 month
Change in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Measured: Baseline to 4 month
Change in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Measured: Baseline to 4 month
Change in resistance training- Handgrip strength
Jamar Plus Digital Hand Dynamometer
Measured: Baseline to 4 month
Change in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Measured: Baseline to 4 month
Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Measured: Baseline to 4 month
Changes in Systolic and Diastolic Blood Pressure
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Measured: Baseline to 4 month
Change in Biomarkers- Lipids
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers- Glycohem
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers- Glucose
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers- C-Peptide
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers- Insulin
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers- hs CRP
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Measured: Baseline to 4 month
Change in Biomarkers-Adipokines- Adiponectin
Adiponectin blood tests
Measured: Baseline to 4 month
Change in Biomarkers-Adipokines- Leptin
Adiponectin blood tests
Measured: Baseline to 4 month
Change in waist circumference
Change in waist circumference measurement
Measured: Baseline to 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Nov 2019
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either a guided or self-guided lifestyle intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago
- Responsible party
- Principal investigator, Melinda Stolley, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321135
- Sponsor's protocol ID
- PRO00030295
- Status last verified
- Dec 2022
- First submitted
- 26 Feb 2020
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04321135
- Acronym / sponsor ID
- PRO00030295
- Conditions
- Breast Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Loyola University Chicago
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 25 Mar 2020 (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 study examine the feasibility and efficacy of Avanzando Juntas, a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with Hispanic/Latina BC \& GC survivors. It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life.
Detailed description
Aim 1. To adapt the Moving Forward weight loss intervention for overweight/obese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee.
Aim 2. To conduct a randomized pilot with 40 overweight/obese Hispanic BCS to establish the feasibility of the adapted Moving Forward program based on recruitment, adherence, retention and efficacy.
Aim 3. To explore the effects of the adapted Moving Forward program (Avanzando Juntas) on anthropometric (weight, % body fat, lean mass), behavioral (dietary intake, physical activity) psychosocial (quality of life) and biological (cholesterol, hemoglobin A1c, adiponectin, leptin, inflammation, insulin resistance) outcomes.
Hypothesis: Women in the weight loss program will exhibit improvements in outcomes compared to women in the wait list control group.
Avanzando Juntas supports BC \& GC survivors in adopting physical activity and eating patterns to promote weight loss, bolster QOL and reduce the risk for comorbidities and, potentially, BC \& GC recurrence. A strong, multidisciplinary study team provides expertise in culturally competent programs for Hispanic BCS, cognitive behavioral lifestyle interventions, body composition, breast cancer and program adaptation.
This study is novel in its focus on weight loss among Hispanic BCS and the incorporation of anthropometric, behavioral, biological and psychosocial outcomes. An additional strength is the foundation of community partnerships that will support the current study's efforts, as well as those for a larger trial, and, if successful, the dissemination of the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either a guided or self-guided lifestyle intervention
| Arm | Type | Receives |
|---|---|---|
| Guided Lifestyle Program | Experimental | Behavioral: Guided Lifestyle Program InterventionThe Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study. |
| Self-Guided Lifestyle Program | Active comparator | Behavioral: Self-Guided Lifestyle Program (Control Arm)In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Self-identify as Hispanic or Latina
- Female
- Stage 0 -III Breast and Gynecological cancer survivors
- Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
- Age >18 at time of diagnosis
Key exclusion criteria (5 listed)
- Plans to move from the community during the study
- A medical condition limiting adherence to diet or physical activity components
- History of significant mental illness
- Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
- Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year
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 |
|---|---|---|
| Guided Lifestyle Program InterventionThe Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines. | Behavioural | Guided Lifestyle Program |
| Self-Guided Lifestyle Program (Control Arm)In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging | Behavioural | Self-Guided Lifestyle Program |
Primary outcome
Change in body composition
Time frame: Baseline to 4 month
Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable
Change in intake of fruits and vegetables
Time frame: Baseline to 4 month
ASA24 dietary analysis of self reported food consumption
Change of intake of red meat/processed meat
Time frame: Baseline to 4 month
ASA24 dietary analysis of self reported food consumption
Change in levels of physical activity- minutes per week
Time frame: Baseline to 4 month
Change of ActiGraph monitored activity
Change in levels of physical activity- #times per week
Time frame: Baseline to 4 month
Change of ActiGraph monitored activity
Change in resistance training- Handgrip strength
Time frame: Baseline to 4 month
Jamar Plus Digital Hand Dynamometer
Change in resistance training- Strength and endurance
Time frame: Baseline to 4 month
30-Second Chair Stand (Sit to Stand)
Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
Time frame: Baseline to 4 month
Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.
Changes in Systolic and Diastolic Blood Pressure
Time frame: Baseline to 4 month
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Change in Biomarkers- Lipids
Time frame: Baseline to 4 month
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Glycohem
Time frame: Baseline to 4 month
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Glucose
Time frame: Baseline to 4 month
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- C-Peptide
Time frame: Baseline to 4 month
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Insulin
Time frame: Baseline to 4 month
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- hs CRP
Time frame: Baseline to 4 month
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Adiponectin
Time frame: Baseline to 4 month
Adiponectin blood tests
Change in Biomarkers-Adipokines- Leptin
Time frame: Baseline to 4 month
Adiponectin blood tests
Change in waist circumference
Time frame: Baseline to 4 month
Change in waist circumference measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Lifestyle Program Intervention in people with Breast Cancer and Gynecologic Cancer, run by Medical College of Wisconsin 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 16 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: Baseline to 4 month). The study lists 18 primary outcomes in all. 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 16 Dec 2022.