Evaluation of a Physical Activity Program in Overweight Breast Cancer Patients

NCT02424292 | Completed

• 2 other identifiers: I-MoveNL44459.042.13
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 4

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%.

Conditions

Breast Cancer

Keywords

Breast cancer; Physcial activity/exercise; anti-hormonal treatment

Outcome Measures

Primary Outcomes (1)

• Measure by accelerometry whether patients meet Dutch PA guidelines for overweight/obese people.

  measured in minutes per week \>3 METs was attained

  12 weeks

Secondary Outcomes (1)

• Measure whether possible change in physical activity is sustained up to 3 months.

  26 weeks

Study Arms (1)

Physical activity

Physical activity in a personalised program

Other: Physical activity

Interventions

Physical activity OTHER

Physical activity in a personalised program.

Physical activity

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female breast cancer patients treated with hormonal therapy in adjuvant setting and a BMI≥ 25 kg/m2

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Pink Ribbon Inc.: collaborator

Study Sites (4)

Wilhelmina Ziekenhuis

Assen, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

UMCG

Groningen, Netherlands

Location

OZG

Winschoten, Netherlands

Location

Related Publications (1)

• Ormel HL, Schroder CP, van der Schoot GGF, Westerink NL, van der Velden AWG, Poppema B, Vrieling AH, Gietema JA, Walenkamp AME, Reyners AKL. Effects of supervised exercise during adjuvant endocrine therapy in overweight or obese patients with breast cancer: The I-MOVE study. Breast. 2021 Aug;58:138-146. doi: 10.1016/j.breast.2021.05.004. Epub 2021 May 15.

  PMID: 34023558 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• A. KL Reyners, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 23, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2021
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (4)