search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Weight loss intervention
Sponsored by
Institut Català d'Oncologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Survivors, Weight loss, Diet, Physical activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Instituto Catalá de Oncología

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm weight loss intervention

Arm 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.

Outcomes

Primary Outcome Measures

Weight loss
Loss 3% of the initial weight

Secondary Outcome Measures

Quality of life
EORTC QLQ-C30 and BR23 mean scores

Full Information

First Posted
February 18, 2014
Last Updated
February 19, 2014
Sponsor
Institut Català d'Oncologia
search

1. Study Identification

Unique Protocol Identification Number
NCT02067481
Brief Title
Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
Acronym
PREDICOP-F
Official Title
Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Català d'Oncologia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Survivors, Weight loss, Diet, Physical activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-arm weight loss intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss intervention
Other Intervention Name(s)
Dietary and Physical Activity Intervention
Intervention 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 (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.
Primary Outcome Measure Information:
Title
Weight loss
Description
Loss 3% of the initial weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
EORTC QLQ-C30 and BR23 mean scores
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
Blood analysis: Biomarkers related to glucose, lipid profile, IGF1, reproductive hormones, leptin, adiponectin, carotenoids, inflammation markers, oxidative stress markers and hematologic parameters, will be analysed
Time Frame
3 months
Title
Cardiorespiratory fitness
Description
To determine peak oxygen uptake (VO2peak), an incremental cycle-ergometer test with monitoring ECG will be performed by exercise physiologists after a 24h period without physical activity in the Physiology Department of the University of Barcelona
Time Frame
3 months
Title
Dietary habits
Description
A validated food frequency questionnaire will be used, designed to capture dietary habits, 24-hour dietary recalls (covering week days and weekends) will be taken to calculate the patients' energy intake and nutritional profile.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Agudo, MsC PhD
Organizational Affiliation
Institut Catalá de Oncología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Catalá de Oncología
City
Barcelona
State/Province
L´Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs