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Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer

NCT03712176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2022-03-22

No results posted yet for this study

Summary

Scientific context: With more than one million cases per year, breast cancer is the most common female cancer. All treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. These treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. Sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. Cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration

Fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. These symptoms can lead to an alteration of the quality of life. The chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. To limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended.

According to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway.

Research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.The investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.

Conditions

Interventions

BEHAVIORAL

Lifestyle alteration

Patients will receive self-report questionnaires to evaluate their quality of life, fatigue level, anxiety and depression, cognitive complaint, cognitive efficiency, nutritional quality and food preferences, and sedentary behavior. Patients will also do tests to determine their physical conditions : six-minute walk test (6MWT), 30-s chair-stand test. The intervention will be done at three stages of the patient's care pathway: 1 / before the adjuvant surgery (baseline), 2 / at 6 months after the surgery and chemotherapy 3 / at 7 months after radiotherapy treatment.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Sophie JACQUIN-COURTOIS, MD · Hospices Civils de Lyon

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2020-10-19
Completion
2020-10-19

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712176 on ClinicalTrials.gov