Plain English Summary
Background and study aims
Being overweight or obese puts you at a higher risk for health problems such as heart disease, stroke, high blood pressure and diabetes, and is also associated with an increased risk of developing many forms of cancer, including breast cancer. There is also evidence that being overweight increases the risk of recurrence and death in patients diagnosed with breast cancer. We think that diet and/or exercise counseling could help overweight or obese breast cancer patients to lose weight, which could in turn improve their quality of life and general health status, and in the long term reduce the risk of breast cancer recurrence. We aim to find out about the effects of 6 months of counseling focused on weight loss in a group of overweight or obese women previously treated for early breast cancer. The counseling is designed to promote a healthy diet or/and to increase exercise and decrease sedentary (sitting) time.
Who can participate?
Breast cancer patients aged 18 or older who are overweight or obese.
What does the study involve?
Participant are randomly allocated to one of four groups: diet counseling, exercise counseling, both diet and exercise counseling, or minimal counseling. Women allocated to the diet and/or exercise counseling groups are offered individual counseling consisting of face-to face contact, group meetings, motivational phone calls and information pamphlets. Participants are given a pedometer device (wrist band) in order to monitor their physical activity and sedentary time. Diet, quality of life, health status and participants' anxiety are assessed with questionnaires. Blood samples are collected at the start of the study and follow-up visits.
What are the possible benefits and risks of participating?
The expected result is weight loss in any of the diet or physical activity groups. Other expected long-term results include long-term weight control, increased physical fitness, increased physical activity, reduced sedentary time, healthier diet, improved health status and quality of life. We do not foresee any serious side effects. However, if participants will experience side effects, this will be reported immediately to the attention of the clinical staff. All participants will be monitored to prevent any possible deficiency or inadequate nutrient and/or calorie intake by evaluating their dietary intake. Participants will also be monitored for injuries or problems associated with the increased physical activity.
Where is the study run from?
European Institute of Oncology (IEO), Milan, Italy
When is the study starting and how long is it expected to run for?
March 2014 to December 2018
Who is funding the study?
The Italian Association for Cancer Research (Associazione Italiana per la Ricerca sul Cancro [AIRC]) (Italy)
Who is the main contact?
1. Patrick Maisonnevue (public)
2. Patrizia Gnagnarella (scientific)
Trial website
Contact information
Type
Public
Primary contact
Dr Patrizia Gnagnarella
ORCID ID
http://orcid.org/0000-0002-0560-4706
Contact details
European Institute of Oncology
Division of Epidemiology and Biostatistics
Via Adamello
6
Milan
20139
Italy
Type
Scientific
Additional contact
Dr Patrick Maisonneuve
ORCID ID
Contact details
European Institute of Oncology
Division of Epidemiology and Biostatistics
Via Adamello
6
Milan
20139
Italy
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IEO-0244
Study information
Scientific title
Promoting weight loss through diet and exercise in overweight women with breast cancer: a four-arm randomized trial - InForma study
Acronym
InForma
Study hypothesis
We hypothesized that individual dietary and/or exercise counseling could help overweight or obese breast cancer patients to lose weight, which could in turn improve their hormonal status, quality of life and general health status, and at long term limit their risk of developing breast cancer recurrence.
Ethics approval
Ethical Committee of the European Institute of Oncology, 01/04/2015 , ref: n. R233/15 –IEO 244
Study design
Mono-institutional randomized controlled four-arm parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Overweight or obese breast cancer patients
Intervention
We will randomize overweight or obese patients into four intervention arms:
1. Dietary Intervention (DI)
2. Physical Activity Intervention (PAI)
3. Physical Activity And Dietary Intervention (PADI)
4. Less Intensive Intervention (LII)
Women allocated to the dietary intervention and/or physical activity intervention arms will be offered an individualized dietary and/or physical activity counseling consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets. All participants will be given a pedometer device (wrist band) in order to monitor (in the two physical activity arms) participants’ physical activity and sedentary time. Dietary intake for all participants will be repeatedly assessed with validated food frequency questionnaires. Quality of life, health status and participants' anxiety will be assessed with self-administered questionnaires including FACT-B and the State-Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected at baseline and follow-up visit to assess glucose, insulin, lipid and hormone profile. Women allocated to the less intensive intervention (or minimal counseling) arm will be considered as control group.
Participants will be followed up for a further 18 months and outcome assessments will be made at 12 and 24 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Change in body weight (weight loss ≥5% of the baseline body weight) at the end of the 6-month intervention
Secondary outcome measures
The secondary outcome measures will be assessed along intervention including:
1. Maintain long-term weight control, measured at baseline, 6 months, 12 months and 24 months
2. Increase physical activity levels and reduce physical inactivity from baseline, measured at baseline, 6 months, 12 months and 24 months
3. Change in dietary intake (increase adherence to healthy diet from baseline), measured at baseline, 6 months and 24 months
4. Evaluate the effect of intervention on long-term breast cancer recurrence
5. Change in health status and quality of life, measured at baseline, 6 months, 12 months and 24 months
6. Evaluate the effect of intervention on blood lipid profile (total cholesterol, LDL and HDL cholesterol, triglycerides), measured at baseline, 6 months and 24 months
7. Evaluate the effect of intervention on biomarkers (estradiol, C-reactive protein (CRP), insulin, glucose), measured at baseline, 6 months and 24 months
Overall trial start date
01/03/2014
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 18 or older
2. Written informed consent obtained
3. Willing to be randomized to either group
4. Histological breast cancer diagnosis
5. BMI comprised between 25 and 40 kg/m2
6. Within one year/6 months of completion of main cancer treatment
7. Willing to wear the wrist-based activity monitor during the 6-month study period
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
260
Participant exclusion criteria
1. Unable to find transportation to the study location over the study period
2. Plan to move away from Lombardy or to be out of town for more than 3 weeks during the study period
3. Investigator does not approve participation in the study in case of:
3.1. History of heart condition, stroke, chest pain during activity or rest
3.2. Severe hypertension
3.3. Patient is unable to walk for exercise (self-report)
3.4. Symptoms of alcohol or substance dependence
3.5. Recent hip fracture, hip or knee replacement, spinal surgery or other orthopedic complications that would prevent optimal participation in the physical activities prescribed
4. Any other severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period
5. Participant already participates to a physical activity or diet intervention trial
6. Participant currently uses an activity monitor device
Recruitment start date
01/10/2015
Recruitment end date
01/10/2016
Locations
Countries of recruitment
Italy
Trial participating centre
European Institute of Oncology
Via Ripamonti, 435
Milan
20141
Italy
Sponsor information
Organisation
European Institute of Oncology (Italy)
Sponsor details
Via Ripamonti
435
Milan
20141
Italy
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Associazione Italiana per la Ricerca sul Cancro
Alternative name(s)
Italian Association for Cancer Research, AIRC Foundation for Cancer Research in Italy, Fondazione AIRC per la Ricerca sul Cancro, AIRC
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Italy
Results and Publications
Publication and dissemination plan
1. Protocol publication in a international peer-reviewed journal
2. The results will be presented in national and international scientific meetings
2. Publication in national journals and international peer-reviewed journals
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27464488