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Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial.
Trials 2016; 17:363T

Abstract

BACKGROUND

Most women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the baseline body weight) in a group of overweight or obese breast cancer survivors.

METHODS/DESIGN

This is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants' dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants' quality of life and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group.

DISCUSSION

While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors.

TRIAL REGISTRATION

ISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015).

Authors+Show Affiliations

Division of Epidemiology and Biostatistics, European Institute of Oncology, Via Adamello, 16, 20139, Milan, Italy. patrizia.gnagnarella@ieo.it.Division of Epidemiology and Biostatistics, European Institute of Oncology, Via Adamello, 16, 20139, Milan, Italy.Physiotherapy Unit, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy.Physiotherapy Unit, European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy.Dietetic and Clinical Nutrition Unit, European Institute of Oncology, Via Ripamonti, 435, 20141, Milan, Italy.Department of Oncology and Hemato-oncology, University of Milan, Via Festa del Perdono, 7, 20122, Milan, Italy. Applied Research Division for Cognitive and Psychological Sciences, European Institute of Oncology, Via Ripamonti, 435, 20141, Milan, Italy.Division of Breast Surgery, European Institute of Oncology, Via Ripamonti, 435, 20141, Milan, Italy.Department of Oncology and Hemato-oncology, University of Milan, Via Festa del Perdono, 7, 20122, Milan, Italy. Applied Research Division for Cognitive and Psychological Sciences, European Institute of Oncology, Via Ripamonti, 435, 20141, Milan, Italy.Division of Epidemiology and Biostatistics, European Institute of Oncology, Via Adamello, 16, 20139, Milan, Italy.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27464488

Citation

Gnagnarella, Patrizia, et al. "Promoting Weight Loss Through Diet and Exercise in Overweight or Obese Breast Cancer Survivors (InForma): Study Protocol for a Randomized Controlled Trial." Trials, vol. 17, 2016, p. 363.
Gnagnarella P, Dragà D, Baggi F, et al. Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials. 2016;17:363.
Gnagnarella, P., Dragà, D., Baggi, F., Simoncini, M. C., Sabbatini, A., Mazzocco, K., ... Maisonneuve, P. (2016). Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials, 17, p. 363. doi:10.1186/s13063-016-1487-x.
Gnagnarella P, et al. Promoting Weight Loss Through Diet and Exercise in Overweight or Obese Breast Cancer Survivors (InForma): Study Protocol for a Randomized Controlled Trial. Trials. 2016 07 28;17:363. PubMed PMID: 27464488.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. AU - Gnagnarella,Patrizia, AU - Dragà,Daniele, AU - Baggi,Federica, AU - Simoncini,Maria Claudia, AU - Sabbatini,Annarita, AU - Mazzocco,Ketti, AU - Bassi,Fabio Domenico, AU - Pravettoni,Gabriella, AU - Maisonneuve,Patrick, Y1 - 2016/07/28/ PY - 2016/02/02/received PY - 2016/06/21/accepted PY - 2016/7/29/entrez PY - 2016/7/29/pubmed PY - 2017/12/6/medline KW - Body composition KW - Breast cancer survivors KW - Counseling KW - Diet KW - Pedometer KW - Physical activity KW - Prevention KW - Quality of life KW - Randomized controlled trial KW - Weight loss SP - 363 EP - 363 JF - Trials JO - Trials VL - 17 N2 - BACKGROUND: Most women with breast cancer experience a progressive weight gain during and after treatment. Obesity is associated with an increased risk of recurrence, contralateral breast cancer, and death. Physical activity after cancer diagnosis has been reported to have positive effects on body composition and quality of life. We present the protocol of the InForma study, a trial testing the efficacy of an intervention on weight loss (≥5 % of the baseline body weight) in a group of overweight or obese breast cancer survivors. METHODS/DESIGN: This is a four-arm randomized controlled trial. Patients will receive a 6-month intervention and be followed for a further 18 months. Intervention is designed to improve adherence to a healthy diet and/or to increase physical activity, taking advantage of a wrist-based activity monitor. Participants will be recruited among overweight or obese breast cancer patients treated at the European Institute of Oncology, after completion of eventual adjuvant chemotherapy and/or radiotherapy. It is envisaged that 260 patients will be randomized into four arms: Dietary Intervention; Physical Activity Intervention; Physical Activity and Dietary Intervention; and Less Intensive Intervention. Women will be offered individualized counseling consisting of face-to face discussion and phone calls in addition to group meetings. A motivational interviewing approach will be used to encourage health behavior change. All participants will be given a pedometer device to monitor their physical activity. Participants' dietary intake will be repeatedly assessed using a validated food frequency questionnaire. Participants' quality of life and anxiety will be assessed with the Functional Assessment of Cancer Therapy-Breast and the State-Trait Anxiety Inventory questionnaires. Blood samples will be collected at baseline and follow-up visits to assess lipid and hormone profiles. Body composition will be repeatedly assessed using bioelectrical impedance vector analysis for identifying changes of fat and fat-free mass. Women allocated to the less intensive intervention arm will be considered as the control group. DISCUSSION: While there is a rising concern about the role of obesity in cancer recurrence and survival, this trial with its multi-arm design, motivational approach and use of a pedometer device will provide important insights regarding the most effective approach in promoting weight control in breast cancer survivors. TRIAL REGISTRATION: ISRCTN53325751 (registration date: 16 October 2015); ClinicalTrials.gov NCT02622711 (registration date: 2 December 2015). SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/27464488/Promoting_weight_loss_through_diet_and_exercise_in_overweight_or_obese_breast_cancer_survivors__InForma_:_study_protocol_for_a_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -