Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer (SPENCER)
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Saint-Genis-Laval, 프랑스
- Hôpital Henry Gabrielle
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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)
|
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).
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The evolution of the quality of life
기간: Cohorte 1 : at 7 months after radiotherapy treatment / Cohorte 2 : at 10 weeks after radiotherapy treatment
|
The evolution of the quality of life will be evaluated by the FACT-B questionnaire (Functional Assessment of Breast Cancer Therapy).
The FACT-B is a 37-item questionnaire divided into five subscales namely physical, social/family, emotional, functional well-beings, and the additional concerns for breast cancer.
Each item is rated on a 5-point Likert scale.
The FACT-B total score is the sum of scores of all five subscales.
|
Cohorte 1 : at 7 months after radiotherapy treatment / Cohorte 2 : at 10 weeks after radiotherapy treatment
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Sophie JACQUIN-COURTOIS, MD, Hospices Civils de Lyon
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .