Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
Health Education Intervention in Reducing Weight Gain in Patients With Newly Diagnosed Stage I-IV Breast Cancer Undergoing Chemotherapy
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.
Inclusion Criteria:

 -  Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds
 of chemotherapy

 -  3.1.2 Women who are receiving, or scheduled to receive, one of the following classes
 of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes,
 cyclophosphamide, or trastuzumab. Participants must be within their first two rounds
 of chemotherapy - Body mass index (BMI) > 20

 -  Treating physician approval to participate in study

 -  Ability to understand and the willingness to sign an Institutional Review Board
 (IRB)-approved informed consent document

 Exclusion Criteria:

 -  Diagnosis of recurrent breast cancer

 -  Women who are already participating in a formal or medically prescribed weight
 management program

 -  Women who have already completed more than two rounds of chemotherapy

 -  Women who are pregnant or nursing