Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Weight loss intervention

• Registration Number: NCT02067481
• Lead Sponsor: Institut Català d'Oncologia

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-19
• Last Update Submitted: 2014-02-19
• Study First Posted: 2014-02-20
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-arm weight loss intervention	Weight loss intervention	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.

Primary Outcome Measures

Name	Time	Method
Weight loss	3 months	Loss 3% of the initial weight

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 months	EORTC QLQ-C30 and BR23 mean scores

Trial Locations

Locations (1)

Instituto Catalá de Oncología; 🇪🇸 Barcelona, L´Hospitalet de Llobregat, Spain