Breast CancerSPENCERNCT03712176
Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer
An observational study of Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lifestyle alteration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2018to 19 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women between 18 and 65 years old with first non-metastatic breast cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Lifestyle alteration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle alterationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Lifestyle alteration | |
| 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). Receives: Behavioral: Lifestyle alteration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evolution of the quality of life
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.
Measured: Cohorte 1 : at 7 months after radiotherapy treatment / Cohorte 2 : at 10 weeks after radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start27 Nov 2018
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie JACQUIN-COURTOIS, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712176
- Sponsor's protocol ID
- 69HCL18_0310
- Acronym
- SPENCER
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT03712176
- Acronym / sponsor ID
- SPENCER / 69HCL18_0310
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : chemotherapy and radiotherapy | – | Behavioral: Lifestyle alteration50 women aged between 18 and 65 with first non-metastatic breast cancer treated by surgery and adjuvant therapy (chemotherapy and radiotherapy) |
| Cohort 2 : radiotherapy only | – | Behavioral: Lifestyle alteration150 women aged between 18 and 65 with first non-metastatic breast cancer treated with surgery and adjuvant therapy (radiotherapy only). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women between 18 and 65 years old with first non-metastatic breast cancer
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle alterationPatients 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. | Behavioural | Cohort 1 : chemotherapy and radiotherapy, Cohort 2 : radiotherapy only |
Primary outcome
The evolution of the quality of life
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie JACQUIN-COURTOIS, MD study director
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution of the quality of life (time frame: Cohorte 1 : at 7 months after radiotherapy treatment / Cohorte 2 : at 10 weeks after radiotherapy treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.