This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.
PRIMARY OBJECTIVES: I. To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants. II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored. III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial. IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit. OUTLINE: Participants undergo four 30-60 minute health education sessions and 3 follow-up phone sessions with an interventionist trained in behavioral science, physical activity and nutrition, and positive psychology over 12 months. EDUCATION SESSION I: Participants receive information from the interventionist concerning healthy diet choices and exercise and begin to keep a food log. EDUCATION SESSION II: Interventionists review information from session I and patient food logs. Participants receive recommendations for exercise and set activity goals. EDUCATION SESSION III: Participants receive information on how to determine portion sizes and the importance of strength training and building lean muscle mass. EDUCATION SESSION IV: Interventionists review information from the previous 3 sessions and discuss the importance of planning and goal setting with participants. The interventionist also discusses physical and mental barriers to exercise. After completion of the education sessions, patients receive 3 phone calls at times convenient to the patient to answer questions about information learned in previous educational sessions. After completion of study, participants are followed up for 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
Undergo health education program
Undergo health education program
Receive follow-up phone calls
Ancillary studies
Ancillary studies
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.
Time frame: Baseline
Effect of the intervention on body composition
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure analysis of covariance (ANCOVAs) to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on self-efficacy
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on perceived stress
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on fatigue
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on 6 minute walk distance
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on fruit, vegetable, and fat intake
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on physical activity participation
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Effect of the intervention on health-related quality of life
Descriptive statistics consisting of frequency tables and percents for categorical variables and means, medians, standard deviations, and ranges for continuous variables will be tabulated. Repeated-measure ANCOVAs to test for change in our primary variables over the 3 timepoints will be conducted, controlling for baseline differences. Additionally, effect sizes will be calculated as they account for sample size and are useful when a lack of power leads to nonsignificant findings. These estimates of variability will be used when designing a future trial.
Time frame: Up to 52 weeks
Sample size for future larger trials
Data from outcomes 1 and 2 along with qualitative data, will allow researchers to refine the protocol accordingly.
Time frame: Up to 52 weeks
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