Comprehensive Lifestyle Change To Prevent Breast Cancer
Słowa kluczowe
Abstrakcyjny
Opis
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.
Daktyle
Ostatnia weryfikacja: | 11/30/2019 |
Pierwsze przesłane: | 02/15/2018 |
Szacowana liczba przesłanych rejestracji: | 02/20/2018 |
Wysłany pierwszy: | 02/26/2018 |
Ostatnia aktualizacja przesłana: | 12/19/2019 |
Ostatnia opublikowana aktualizacja: | 12/22/2019 |
Rzeczywista data rozpoczęcia badania: | 04/03/2019 |
Szacowana data zakończenia podstawowej działalności: | 08/31/2022 |
Szacowana data zakończenia badania: | 08/31/2022 |
Stan lub choroba
Interwencja / leczenie
Other: Group I (IO prevention program)
Other: Questionnaire Administration
Faza
Grupy ramion
Ramię | Interwencja / leczenie |
---|---|
Experimental: 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. | Other: Group I (IO prevention program) Attend IO prevention program |
Active Comparator: Group II (no intervention) Patients receive no intervention. After 26 weeks, patients may crossover to Group I. |
Kryteria kwalifikacji
Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
Płeć kwalifikująca się do nauki | Female |
Przyjmuje zdrowych wolontariuszy | tak |
Kryteria | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Wynik
Podstawowe miary wyników
1. Consent rate [Up to 1 year]
2. Treatment group compliance rate [Up to 1 year]
3. Retention rate [Up to 1 year]
Miary wyników wtórnych
1. Group differences over time in biological pathways [Up to 1 year]
2. Group differences over time in dietary patterns [Up to 1 year]
3. Group differences over time in fitness levels [Up to 1 year]
4. Group differences over time in percent body fat [Up to 1 year]
5. Group differences over time in anthropometrics [Up to 1 year]
6. Gut microbiome [Up to 1 year]