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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DI
PAI
PADI
LII
Sponsored by
European Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, obesity, weight control, exercise and physical fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • IEO Istituto Europeo di Oncologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

DI Dietary Intervention

PAI Physical Activity Intervention

PADI Physical Activity+Diet Intervention

LII Less Intensive Intervention

Arm Description

Individualized dietary counselling to reduce body weight

Individualized physical activity counseling to reduce body weight

Individualized dietary and physical activity counseling to reduce body weight

Materials and guidelines available to general public

Outcomes

Primary Outcome Measures

Body weight reduction
weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer

Secondary Outcome Measures

Long-term body weight control
long-term weight control or maintenance via calibrated scales, stadiometer
Pedometer Step Count
change in total step count via pedometer device with electronic data transmission
Physical activity level
change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire
Dietary intake
change in dietary intake via Food Frequency Questionnaire
Quality of life
change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)
Mood
change in mood via State-Trait Anxiety Inventory (STAI) questionnaires
Lipid Marker Change
change in LDL, HDL, triglycerides and cholesterol assessed by blood samples
Oestradiol level
change in oestradiol assessed by blood samples
Insulin level
change in insulin assessed by blood samples
Glucose level
change in glucose assessed by blood samples
C-reactive protein level
change in C-reactive protein assessed by blood samples

Full Information

First Posted
November 6, 2015
Last Updated
January 29, 2020
Sponsor
European Institute of Oncology
Collaborators
Associazione Italiana per la Ricerca sul Cancro
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1. Study Identification

Unique Protocol Identification Number
NCT02622711
Brief Title
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer
Acronym
InForma
Official Title
Promoting Weight Loss Through Diet and Exercise in Overweight Women With Breast Cancer: A Four-arm Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology
Collaborators
Associazione Italiana per la Ricerca sul Cancro

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, obesity, weight control, exercise and physical fitness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DI Dietary Intervention
Arm Type
Experimental
Arm Description
Individualized dietary counselling to reduce body weight
Arm Title
PAI Physical Activity Intervention
Arm Type
Experimental
Arm Description
Individualized physical activity counseling to reduce body weight
Arm Title
PADI Physical Activity+Diet Intervention
Arm Type
Experimental
Arm Description
Individualized dietary and physical activity counseling to reduce body weight
Arm Title
LII Less Intensive Intervention
Arm Type
Experimental
Arm Description
Materials and guidelines available to general public
Intervention Type
Behavioral
Intervention Name(s)
DI
Other Intervention Name(s)
Dietary Intervention
Intervention Description
Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
Intervention Type
Behavioral
Intervention Name(s)
PAI
Other Intervention Name(s)
Physical Activity Intervention
Intervention Description
Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
Intervention Type
Behavioral
Intervention Name(s)
PADI
Other Intervention Name(s)
Physical Activity and Dietary Intervention
Intervention Description
Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
Intervention Type
Behavioral
Intervention Name(s)
LII
Other Intervention Name(s)
Less Intensive Intervention
Intervention Description
Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.
Primary Outcome Measure Information:
Title
Body weight reduction
Description
weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer
Time Frame
baseline - 6 month
Secondary Outcome Measure Information:
Title
Long-term body weight control
Description
long-term weight control or maintenance via calibrated scales, stadiometer
Time Frame
baseline - 12 month - 24 month
Title
Pedometer Step Count
Description
change in total step count via pedometer device with electronic data transmission
Time Frame
baseline - 6 month - 12 month - 24 month
Title
Physical activity level
Description
change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire
Time Frame
baseline - 6 month - 12 month - 24 month
Title
Dietary intake
Description
change in dietary intake via Food Frequency Questionnaire
Time Frame
baseline - 6 month - 24 month
Title
Quality of life
Description
change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time Frame
baseline - 6 month - 12 month - 24 month
Title
Mood
Description
change in mood via State-Trait Anxiety Inventory (STAI) questionnaires
Time Frame
baseline - 6 month - 12 month - 24 month
Title
Lipid Marker Change
Description
change in LDL, HDL, triglycerides and cholesterol assessed by blood samples
Time Frame
baseline - 6 month - 24 month
Title
Oestradiol level
Description
change in oestradiol assessed by blood samples
Time Frame
baseline - 6 month - 24 month
Title
Insulin level
Description
change in insulin assessed by blood samples
Time Frame
baseline - 6 month - 24 month
Title
Glucose level
Description
change in glucose assessed by blood samples
Time Frame
baseline - 6 month - 24 month
Title
C-reactive protein level
Description
change in C-reactive protein assessed by blood samples
Time Frame
baseline - 6 month - 24 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Maisonneuve
Organizational Affiliation
European Institue of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
IEO Istituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27464488
Citation
Gnagnarella P, Draga D, Baggi F, Simoncini MC, Sabbatini A, Mazzocco K, Bassi FD, Pravettoni G, Maisonneuve P. Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials. 2016 Jul 28;17:363. doi: 10.1186/s13063-016-1487-x.
Results Reference
derived

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

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