Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors (PREDICOP-F)

Institut Català d'Oncologia

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Behavioral: Weight loss intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02067481

PREDICOP-F

Details and patient eligibility

About

This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Full description

Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients from the Catalan Institute of Oncology
• Aged 18 to 75
• Body mass index (BMI) of 25 kg•m-2 or more
• Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

Exclusion criteria

• First cancer, tumours of stage IIIB and above
• Morbid obesity (BMI ≥40 kg•m-2)
• Any condition that could not permit to follow the diet and PA intervention offered

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Single-arm weight loss intervention

Experimental group

Description:

This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (AP) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment.

Treatment:

Behavioral: Weight loss intervention