NEXT (Nutrition and EXercise During Adjuvant Treatment) Study (NExT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study will offer a supervised exercise program and healthy eating education to women with breast cancer undergoing chemotherapy as a physician-referred program and measure the adoption, adherence and satisfaction with the intervention as well as its health effects. Past trials have demonstrated various health benefits of exercise yet it is not currently part of supportive care and few suitable programs exist in the community or outside of research. This study is expected to address the unique barriers related to exercise in breast cancer survivors and to better understand how the intervention might work in a real life setting.
The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals [ Time Frame: 2 years ]
Secondary Outcome Measures
Means and standard deviations [ Time Frame: 2 years ]
The secondary outcomes will be will be summarized with means and standard deviations for normally distributed data and assessed by repeated measures ANOVA to examine change over time
Other Outcome Measures:
Healthcare Utilization costs [ Time Frame: 2 years ]
The exploratory outcomes will be assessed by proportion of participants responses for the patient satisfaction items and healthcare utilization costs will be analyzed by collaborators with the Canadian Centre for Applied Research in Cancer (ARCC).
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Ages Eligible for Study:
19 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
aged 19 years and older;
newly diagnosed with early stage (I-IIIA) breast cancer;
prescribed adjuvant chemotherapy (with or without radiation) as part of curative treatment for breast cancer; and
good comprehension of English
contraindications for entry into an exercise program (i.e., known cardiovascular disease, uncontrolled diabetes mellitus, or musculoskeletal impairment issue);
body mass index (BMI) >40 (morbid obesity);
mobility impairment requiring use of mobility aids;
stage IV cancer
neo-adjuvant chemotherapy (with likelihood of surgery after chemotherapy)
Gender exclusion criteria: Male breast cancer is excluded as it is a rare diagnosis.
Age exclusion criteria: Based on enrolling adult participants only. Language exclusion criteria: A good comprehension of English is required to receive instruction on the intervention and complete study forms and evaluations.