Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma) : study protocol for a randomized controlled trial

Most women with breast cancer experience a progressive weight gain during and after treatment.
Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity
after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We
present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the
baseline body weight) in a group of overweight or obese breast cancer survivors.
This is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and
be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to
increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among
overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of
eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four
arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less
Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and
phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health
behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants’
dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants’ quality of life
and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety
Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and
hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for
identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be
considered as the control group.
While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial
with its multi-arm design, motivational approach and use of a pedometer device will provide important insights
regarding the most effective approach in promoting weight control in breast cancer survivors.