Comprehensive Lifestyle Change to Prevent Breast Cancer: A Feasibility Trial
概览
- 阶段
- 不适用
- 干预措施
- Cancer Prevention
- 疾病 / 适应症
- Premenopausal
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Consent rate
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.
详细描述
PRIMARY OBJECTIVES: I. Assess the feasibility of a randomized controlled trial involving a mobile, standardized, comprehensive integrative oncology (IO) prevention program. SECONDARY OBJECTIVES: I. Compare group differences over time in biological pathways including: immune function, gut microbiome, endocrine function, insulin and glucose metabolism, inflammation, other cancer-related pathways (from peripheral blood), antioxidant capacity, and nutrient levels. II. Determine whether the IO group has improved patient reported outcomes over time including: quality of life, sleep disturbances, aspects of mental health, and psychosocial measures including: mindfulness, social support, and measures of positive growth. III. Compare group differences over time in dietary patterns, fitness levels, percent body fat, and anthropometrics. OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks. GROUP II: Patients receive no intervention. After 26 weeks, patients may crossover to Group I. After completion of study, patients are followed up at 26 weeks and 1 year.
研究者
入排标准
入选标准
- •Able to read, write, and speak English
- •Premenopausal
- •A body mass index (BMI) \>= 25
- •Have intact breasts and ovaries
- •Able to provide informed consent to participate in the study
- •Meet all the following criteria related to lifestyle: a) consume less than 3 servings of vegetables (excluding any fried servings) and 1 serving of fruit (not including juice)/day; b) engage in less than 150 minutes 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); c) engage in a mind-body practice less once per week
- •Able mentally and physically to participate in interventions in this study (Note: If there are one or more positive responses to the Physical Activity Readiness Questionnaire \[PARQ\], then a physician-release for exercise is required prior to obtaining consent)
- •Access to internet connection
- •Able to come to University of Texas (UT) MD Anderson for the orientation and assessment sessions
排除标准
- •Any personal history of cancer, including ductal carcinoma in situ (DCIS) and not including non-melanoma skin cancers
- •Any major thought disorder (e.g., schizophrenia, dementia)
- •Communication barriers (e.g. hard of hearing)
- •Poorly or uncontrolled diabetes in the opinion of the physician(s)
- •Being pregnant or planning on becoming pregnant within the next year
- •Contemplating any new pharmacologic/hormonal or prophylactic surgical intervention for breast cancer prevention within the next year (Note: Individuals taking tamoxifen, arimidex or other hormonal prevention strategies at time of consent will be eligible)
研究组 & 干预措施
Group I (IO prevention program)
Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.
干预措施: Cancer Prevention
Group I (IO prevention program)
Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.
干预措施: Questionnaire Administration
Group II (no intervention)
Patients receive no intervention. After 26 weeks, patients may crossover to Group I.
干预措施: Questionnaire Administration
结局指标
主要结局
Consent rate
时间窗: Up to 1 year
Will calculate the rates, frequencies, and 90% confidence intervals (CIs) of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Treatment group compliance rate
时间窗: Up to 1 year
Will be defined as attending at least 50% of sessions during the intervention delivery weeks (first 26 weeks) in the integrative oncology (IO) group. Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
Retention rate
时间窗: Up to 1 year
Will calculate the rates, frequencies, and 90% CIs of means by group, as well as for the differences between intervention groups as applicable. Will also examine demographic factors such as age, marital status, number of children, and employment status as they related to feasibility in terms of consent, adherence to the intervention, and retention in the study.
次要结局
- Group differences over time in biological pathways(Up to 1 year)
- Group differences over time in percent body fat(Up to 1 year)
- Group differences over time in anthropometrics(Up to 1 year)
- Group differences over time in dietary patterns(Up to 1 year)
- Group differences over time in fitness levels(Up to 1 year)
- Gut microbiome(Up to 1 year)