CompletedNot Applicable

Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

United States173 participantsStarted 2018-01-02

Plain-language summary

The proposed study is a randomized trial evaluating the impact of a dietary and physical activity guidelines intervention vs. usual care on adherence to breast cancer treatments, body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer scheduled to receive neoadjuvant or adjuvant chemotherapy.

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: * Diagnosed with Stage I-III breast cancer * Scheduled to receive neoadjuvant or adjuvant chemotherapy * Physically able to walk * Able to complete forms, understand instructions and read intervention book in English * Agrees to be randomly assigned to either intervention or usual care group Exclusion Criteria: * Women who have completed their 2nd chemotherapy * Women already practicing dietary or physical activity guidelines * Are pregnant or intending to become pregnant in the next year * Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40% * Presence of dementia or major psychiatric disease * Non-English speaking

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Adherence to Treatment Measured by Chemotherapy Completion Rate

Timeframe: before initiating chemotherapy to post-chemotherapy, up to 7 months

Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)

Timeframe: 12 months after enrollment

Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).

Timeframe: 24 months after enrollment

Trial details

NCT IDNCT03314688

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-24

Results submitted2024-03-21

View on ClinicalTrials.gov More Breast Neoplasms trials