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

NCT ID: NCT03712176

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2020-10-19

Brief 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

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1 : chemotherapy and radiotherapy

50 women aged between 18 and 65 with first non-metastatic breast cancer treated by surgery and adjuvant therapy (chemotherapy and radiotherapy)

Lifestyle alteration

Intervention Type: BEHAVIORAL

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.

Cohort 2 : radiotherapy only

150 women aged between 18 and 65 with first non-metastatic breast cancer treated with surgery and adjuvant therapy (radiotherapy only).

Lifestyle alteration

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women between 18 and 65 years old
• Breast invasive or in situ cancer (all histology), unilocal or multilocal tumor
• Treatment by first surgery and adjuvant radiotherapy validated at the multidisciplinary consultation meeting with +/- adjuvant chemotherapy (all chemotherapy)
• Patient reading and understanding the French language
• Non-opposition of patient

Exclusion Criteria

• Patient with a history of treated breast cancer
• Presence of metastasis
• Other cancer or severe disease under evaluation or treatment at baseline (to avoid selection bias)
• Patient with psychiatric disorders
• Patient under protection status
• Pregnant or nursing women or absence of contraception in a patient of childbearing age

Withdrawal Criteria :

• Other cancer or severe illness diagnosed during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie JACQUIN-COURTOIS, MD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Locations

Hôpital Henry Gabrielle

Saint-Genis-Laval, , France

Countries

France

Other Identifiers

69HCL18_0310

Identifier Type: -

Identifier Source: org_study_id