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| Name | Class |
|---|---|
| Associazione Italiana per la Ricerca sul Cancro | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DI Dietary Intervention | Experimental | Individualized dietary counselling to reduce body weight |
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| PAI Physical Activity Intervention | Experimental | Individualized physical activity counseling to reduce body weight |
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| PADI Physical Activity+Diet Intervention | Experimental | Individualized dietary and physical activity counseling to reduce body weight |
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| LII Less Intensive Intervention | Experimental | Materials and guidelines available to general public |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight reduction | weight loss ≥5% of the baseline body weight via calibrated scales, stadiometer | baseline - 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term body weight control | long-term weight control or maintenance via calibrated scales, stadiometer | baseline - 12 month - 24 month |
| Pedometer Step Count | change in total step count via pedometer device with electronic data transmission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Maisonneuve | European Institue of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEO Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41145327 | Derived | Gnagnarella P, Carioni G, Draga D, Raja S, Baggi F, Simoncini MC, Mazzocco K, Masiero M, Bassi FD, Peradze N, Zorzino L, Pravettoni G, Sieri S, Maisonneuve P. Dietary patterns and change in food consumption in overweight or obese breast cancer survivors: the InForma randomized intervention trial. Nutr Metab Cardiovasc Dis. 2026 Feb;36(2):104378. doi: 10.1016/j.numecd.2025.104378. Epub 2025 Oct 16. | |
| 27464488 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009043 | Motor Activity |
| D009068 | Movement |
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|
| PAI | Behavioral | 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. |
|
|
| PADI | Behavioral | 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. |
|
|
| LII | Behavioral | Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public. |
|
|
| baseline - 6 month - 12 month - 24 month |
| Physical activity level | change in physical activity and inactivity levels via IPAQ-International physical activity questionnaire | baseline - 6 month - 12 month - 24 month |
| Dietary intake | change in dietary intake via Food Frequency Questionnaire | baseline - 6 month - 24 month |
| Quality of life | change in quality of life via Functional Assessment of Cancer Therapy-Breast (FACT-B) | baseline - 6 month - 12 month - 24 month |
| Mood | change in mood via State-Trait Anxiety Inventory (STAI) questionnaires | baseline - 6 month - 12 month - 24 month |
| Lipid Marker Change | change in LDL, HDL, triglycerides and cholesterol assessed by blood samples | baseline - 6 month - 24 month |
| Oestradiol level | change in oestradiol assessed by blood samples | baseline - 6 month - 24 month |
| Insulin level | change in insulin assessed by blood samples | baseline - 6 month - 24 month |
| Glucose level | change in glucose assessed by blood samples | baseline - 6 month - 24 month |
| C-reactive protein level | change in C-reactive protein assessed by blood samples | baseline - 6 month - 24 month |
| Derived |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |