NCT02067481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

February 18, 2014

Last Update Submit

February 19, 2014

Conditions

Breast Cancer

Keywords

Breast cancerSurvivorsWeight lossDietPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Loss 3% of the initial weight

    3 months

Secondary Outcomes (1)

  • Quality of life

    3 months

Other Outcomes (3)

  • Biomarkers

    3 months

  • Cardiorespiratory fitness

    3 months

  • Dietary habits

    3 months

Study Arms (1)

Single-arm weight loss intervention

EXPERIMENTAL

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.

Behavioral: Weight loss intervention

Interventions

Weight loss interventionBEHAVIORAL

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.

Also known as: Dietary and Physical Activity Intervention
Single-arm weight loss intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Catalá de Oncología

Barcelona, L´Hospitalet de Llobregat, 08908, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsWeight LossMotor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Antonio Agudo, MsC PhD

    Institut Catalá de Oncología

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2014

First Posted

February 20, 2014

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

ES(1)