Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer (InForma)

European Institute of Oncology

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: LII; Behavioral: PADI; Behavioral: PAI; Behavioral: DI

Study type: Interventional

Funder types: Other

Identifiers

NCT02622711

IEO 0244

Details and patient eligibility

About

The investigators aim to evaluate the effect of a 6-month intervention (counseling) focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. Intervention is designed to improve adherence to a healthy diet or/and to increase physical activity and decrease sedentary time, taking advantage of a pedometer-like device.

Full description

The InForma project is designed as a mono-institutional randomized controlled 4-arm parallel-group trial. Potential study participants will be recruited among all overweight or obese breast cancer patients previously treated at the European Institute of Oncology (IEO). Potential study participants will be recruited after breast cancer treatments (surgery, chemotherapy and and/or radiation) will be completed. Study participants will be randomized to one of the 4 arms: DI - Dietary Intervention; PAI - Physical Activity Intervention; PADI - Physical Activity and Dietary Intervention; LII - Less Intensive Intervention. Enrolled patients will receive a 6-month intervention and will be followed until the end of the study period with two additional follow-up visits at 12- and 24-month. The main aim of the study is to evaluate the impact of the intervention programme on body weight change in overweight or obese breast cancer patients.

Enrollment: 262 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with a first invasive non-metastatic breast carcinoma histologically confirmed,
• BMI > 25,
• within 6-month/one year of completion of main cancer treatment,
• being able to participate in the intervention,
• agree to wear the wrist-based activity monitor during the study period,
• agree to be randomized to either group,
• written informed consent.

Exclusion criteria

• severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period,
• contraindications to exercise due to history of heart condition, stroke, chest pain during activity or rest, severe hypertension
• orthopaedic disability that would prevent optimal participation in the physical activities prescribed,
• patient is unable to find transportation to the study location over the study period, - or
• plans to move away from Lombardy or to be out of town for more than 3 weeks during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

262 participants in 4 patient groups

DI Dietary Intervention

Experimental group

Description:

Individualized dietary counselling to reduce body weight

Treatment:

Behavioral: DI

PAI Physical Activity Intervention

Experimental group

Description:

Individualized physical activity counseling to reduce body weight

Treatment:

Behavioral: PAI

PADI Physical Activity+Diet Intervention

Experimental group

Description:

Individualized dietary and physical activity counseling to reduce body weight

Treatment:

Behavioral: PADI

LII Less Intensive Intervention

Experimental group

Description:

Materials and guidelines available to general public

Treatment:

Behavioral: LII