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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 : Active, not recruiting
First Posted : April 23, 2015
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Pink Ribbon Inc.
Information provided by (Responsible Party):
A.K.L. Reyners, University Medical Center Groningen

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Physical activity
Physical activity in a personalised program
Other: Physical activity
Physical activity in a personalised program.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female breast cancer patients treated with hormonal therapy in adjuvant setting and a BMI≥ 25 kg/m2
Criteria

Inclusion Criteria:

  • Female breast cancer patients
  • Diagnosis of stage I-III breast cancer, currently on adjuvant anti-hormonal treatment
  • BMI ≥ 25 kg/m2
  • Age 18-75 years old
  • Provided informed consent

Exclusion Criteria:

  • Evidence of recurrent/metastatic breast cancer or other primary malignancy
  • Uncontrolled heart disease
  • Other contraindications to exercise training (e.g., orthopaedic problems)
  • Dementia

Information from the National Library of Medicine

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


Locations
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Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
UMCG
Groningen, Netherlands
OZG
Winschoten, Netherlands
Sponsors and Collaborators
University Medical Center Groningen
Pink Ribbon Inc.
Investigators
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Principal Investigator: A. KL Reyners, MD, PhD University Medical Center Groningen

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Responsible Party: A.K.L. Reyners, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02424292    
Other Study ID Numbers: I-Move
NL44459.042.13 ( Other Identifier: ABR form )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2019
Keywords provided by A.K.L. Reyners, University Medical Center Groningen:
Breast cancer
Physcial activity/exercise
anti-hormonal treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight
Signs and Symptoms