Active — Not RecruitingNot Applicable

Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer

United States30 participantsStarted 2021-05-21

Plain-language summary

This clinical trial aims to develop a lifestyle program to improve clinical outcomes in women with breast cancer who do not have a healthy diet, regular exercise habits, or ways to manage their stress well. The program will include support and counseling in healthy eating, physical activity, stress management and mindfulness, learning sleep hygiene techniques, and behavioral counseling in addition to social support. Developing a lifestyle program may help improve quality of life and encourage healthy lifestyle choices among patients diagnosed with breast cancer.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women with stage I-III BCa scheduled to undergo radiation therapy (RT) or within the first 12 months of having completed primary treatment (they do not need to have undergone RT) * Underwent chemotherapy and surgery * Able to read, write, and speak English * BMI of 25 or higher * 18 years of age or older * Oriented to person, place, and time * Participants must meet at least two of the following criteria related to their lifestyle at the time of diagnosis: * Consume less than 3 servings of fruit and vegetable/day * Engage in less than 75 minutes of moderate/vigorous intensity activity per week, defined as anything that causes small increases in breathing or heart rate for a sustained amount of time (e.g., brisk walking, bicycling) * Engage in a mind-body practice less than 4 times a month * Access to internet connection * Access to a tablet, laptop or computer * Able to come to University of Texas (UT) MD Anderson or Wake Forest for blood collection * Able to perform light physical activity. if any medical issues exist or arise that may limit performing physical activity, a medical release will be required Exclusion Criteria: * Have not completed chemotherapy; have a recurrent BCa diagnosis; another primary cancer diagnosis within past 5 years (not including non-melanoma skin cancers) * Any major thought disorder (e.g., schizophrenia, dementia) * Any major communication barriers that would preclude being able to complete the intervention (e.g.,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is described as 'active, not recruiting' — does that mean enrollment is already closed, and if so, are there similar mobile lifestyle programs I could still access or be referred to?
2Since this is a feasibility study rather than a treatment trial, it's focused on whether a mobile lifestyle program can be delivered — not on proving it improves survival or reduces recurrence — so how would participating in something like this fit alongside my actual breast cancer treatment plan?
3The study is designed specifically for women with breast cancer — given my particular diagnosis, stage, and current treatment, would a structured lifestyle intervention like this be appropriate and safe for me right now?
4Mobile health programs require consistent smartphone or device use and self-reporting — is that kind of ongoing digital engagement realistic given where I am in treatment, and would my care team be monitoring my progress or just collecting data?
5Are there already evidence-based lifestyle recommendations — like specific exercise or nutrition guidance — that my care team can offer me now, rather than waiting to see if a program like this becomes more widely available??

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the feasibility of delivering a mobile, standardized, comprehensive lifestyle program in women with BCa.

Timeframe: up to 9 months after study baseline

Trial details

NCT IDNCT05132296

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-15

View on ClinicalTrials.gov More Breast Carcinoma trials