The Role of Lifestyle Factors in Breast Cancer-Related Outcomes (NCT02079662) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Role of Lifestyle Factors in Breast Cancer-Related Outcomes
United States110 participantsStarted 2013-06-13
Plain-language summary
This randomized clinical trial studies an integrative oncology (making changes in lifestyle and behavior) program in improving cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy. An integrative oncology program consisting of dietary recommendations, physical activity, stress management, social support, and control of environmental contaminants may modify cancer-related biological processes, influence long-term treatment results, and improve the quality of life of patients.
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 II or III breast cancer that will be scheduled to undergo a 4 to 6-week course of radiotherapy
* Participants must be able to read, write, and speak English
* Participants must be oriented to person, place, and time
* Participants must also meet at least two of the following criteria related to lifestyle: 1) consume less than 3 servings of fruit and vegetable/day; 2) engage in less than 75 minutes moderate/vigorous 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); and 3) engage in a mind-body practice less than 4 times a month
* Participants must have a body mass index (BMI) of 24.45 or higher as assessed in the medical record
Exclusion Criteria:
* Patients with a recurrent breast cancer diagnosis
* Patients with another primary cancer diagnosis within 5 years of consent, not including non-melanoma skin cancers
* Patients who have any major psychiatric diagnoses or thought disorder (e.g. schizophrenia, bi-polar disorder, dementia)
* Patients with communication barriers (e.g., hard of hearing)
* Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted)
* Patients with poorly or uncontrolled diabetes in the opinion of the physician(s)
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 study is tracking things like diet, fitness, and sleep quality alongside cancer outcomes — given my specific stage II or III breast cancer diagnosis, could participating in this kind of lifestyle monitoring study complement my current treatment plan, or might it create any conflicts?
2Since this trial is no longer actively enrolling, is there a similar ongoing study or lifestyle intervention program at our cancer center that might offer me the same kind of structured support around diet, exercise, and quality of life during treatment?
3The trial is measuring disease-free survival alongside changes in fitness and dietary patterns — what does my doctor currently think is the strongest evidence connecting lifestyle factors like exercise or diet to outcomes for someone at my stage of breast cancer?
4Heart rate variability is one of the things being tracked in this study — is that something my care team is already monitoring, and should I be paying attention to it as a signal of how my body is responding to treatment?
5This study looks at fatigue and sleep disturbances as part of quality of life — given that these are things I'm already experiencing, what resources or programs could my doctor recommend now that address these issues, even if I can't enroll in this particular trial?
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
1
Disease-free survival (DFS)
Timeframe: Up to 5 years
2
Changes in biological pathways
Timeframe: Baseline to 5 years
3
Changes in dietary patterns
Timeframe: Baseline to 5 years
4
Changes in fitness levels
Timeframe: Baseline to 5 years
5
Changes in heart rate variability
Timeframe: Baseline to 5 years
6
Changes in quality of life (including fatigue and sleep disturbances)