Evaluation of a Physical Activity Program in Overweight Breast Cancer Patients (I-Move)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02424292|
Recruitment Status : Completed
First Posted : April 23, 2015
Last Update Posted : February 2, 2021
Patients diagnosed with breast cancer generally have a fairly well prognosis with estimated average survival rates of 73% and five year survival rates of 89% in developed countries. However, women who are obese at the time of breast cancer diagnosis seem to be at risk for a worse breast cancer related and overall survival, as compared to their normal weight counterparts. In addition, weight gain after diagnosis might be negatively associated with prognosis.
Weight gain is a common phenomenon among breast cancer patients receiving adjuvant chemotherapy as well as receiving adjuvant anti-hormonal therapy. While sufficient physical activity and limitation of the amount of weight gain is important for all breast cancer patients, it surely is for overweight and obese patients. The recently published national guideline oncological rehabilitation provides exercise goals, for physical training based on the Dutch PA guideline "Nederlandse Norm Gezond Bewegen (NNGB)". It recommends to engage in moderate-intensity exercise (e.g. brisk walking) for at least 30 minutes a day, on at least 5 days a week. For people who are overweight (Body Mass Index ≥ 25 kg/m2) it is recommended to exercise at least 60 minutes at a moderate-intensity level, equal or more than 3 Metabolic Equivalent Task Hours (> 3 MET/h), on at least 5 days a week. However, only 61% of the general population, meets these guidelines (8) and among cancer patients this percentage is even less. This study aims to increase the percentage of overweight breast cancer patients treated with adjuvant anti-hormonal therapy that reaches the goal of the NNGB by the oncological rehabilitation program with 20%.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: Physical activity|
|Study Type :||Observational|
|Actual Enrollment :||141 participants|
|Official Title:||Evaluating the Outcome of a Personalised Oncological Rehabilitation Program in Overweight and Obese Breast Cancer Patients on Adjuvant Anti-hormonal Treatment "I-Move"|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||January 2021|
Physical activity in a personalised program
Other: Physical activity
Physical activity in a personalised program.
- Measure by accelerometry whether patients meet Dutch PA guidelines for overweight/obese people. [ Time Frame: 12 weeks ]measured in minutes per week >3 METs was attained
- Measure whether possible change in physical activity is sustained up to 3 months. [ Time Frame: 26 weeks ]measured in minutes per week >3 MET was attained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424292
|Principal Investigator:||A. KL Reyners, MD, PhD||University Medical Center Groningen|