Stage IV Breast Cancer Clinical Trial
Official title:
Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During 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.
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