Metastatic Breast CancerEPOCANCT03636776
Quality of Life and Psychological Vulnerability in Patients With RH+ Metastatic Breast Cancer
A study testing Quality of life in metastatic BC in people with Metastatic Breast Cancer and Positive Hormonal Receptors, run by Institut Cancerologie de l'Ouest at 2 sites in France.
Trial summary
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, Positive Hormonal Receptors
- What is being tested?
- Quality of life in metastatic BC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Dec 2016to 11 Jan 2022
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of invasive breast cancer (=infiltrant). NB: Mixed histologies are allowed
- Adult women (≥ 18 years),
- Positive hormonal receptors (Estrogen receptors and/or Progesterone receptors ≥10%) and HER2 negative
- Patient in need of a 1st metastatic treatment line NB: Patients may have received prior treatment for their cancer, but not for their metastatic disease.
- Performance status ≤ 1 (world health organization)
- Patients affiliated to a Social Security,
- Obtaining the patient's signed written consent
Who cannot join
- Patient with non-metastatic breast cancer,
- man
- Negative hormonal receptors or HER2 positive
- Psychiatric history with specialist diagnosis
- Pregnant or nursing patient
- Patients who cannot be followed regularly for psychological reasons (cognitive problems preventing completion of questionnaires), or because of geographical remoteness.
- Person deprived of liberty or adult under guardianship
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.
However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :
- to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
- to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.
Read the detailed description
Studying quality of life over time in patients followed for metastatic breast cancer will identify when a person may feel most vulnerable in their experience of the disease and treatment. A specific and adapted support can thus be set up throughout the disease, from the diagnosis and during the different phases of treatment.
Patients will benefit from a longitudinal follow-up determined according to the treatments. For example :
Chemotherapy : After the first assessment time at 1 month from diagnosis, patients receiving chemotherapy treatment are seen every 3 months.
Hormone therapy : After the first assessment time at 1 month from diagnosis, patients receiving hormone therapy are seen every 2 months.
Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment.
The rhythm of the evaluation visits will therefore be defined by the doctor, according to the habits of the centre.
Patients will complete an end of study visit 3 years after inclusion
Quality of Life and Psychological vulnerability will be assessed through questionnaires :
- QLQ-C30 explores 5 functional scales (physical, social, psychological, cognitive functioning, daily activities) and 1 scale of health status and overall quality of life. It allows a detailed analysis of symptoms related to the disease and its treatment (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) as well as the financial impact for the patient.
- BR23 : specific questionnaire for breast cancer validated in French
- Psychological distress scale (PDS)
- State Trait Anxiety Inventory (STAI) : Assesses the feelings of apprehension, tension, nervousness and worry that the subject feels at the time of the anxiogenic or endangerment situation. This questionnaire is therefore an indicator of transient changes in anxiety caused by aversive or therapeutic situations.
- Beck Depression Inventory (BDI II) : assesses the severity of depression.
- Being tested
- Quality of life in metastatic BC
- Keywords
- Quality of Life, Psychological vulnerability
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life in metastatic BCOther
1 month after metastatic stage diagnosis, patients complete their 1st therapeutic sequence evaluation visit (T1) within the recommended standard time frames. If the disease remains stable or if a response to treatment is observed then patients continue their follow-up in the same therapeutic sequence (T1).
If progression occurs, treatment is modified and patients move on to the next therapeutic sequence (T2).
And so on as many times as necessary. Before each evaluation visit with investigator, patients complete the questionnaires QLQ-C30, BR23, STAI, BDI II
| Study group | Role | What they receive |
|---|---|---|
| quality of life in metastatic BC | Experimental | Patients benefit from a longitudinal follow-up determined according to the treatments.
Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment.
The rhythm of the evaluation visits will therefore be defined by the doctor, according to the habits of the centre.
The evaluation times used to collect the questionnaires (QLQ-C30, BR23, PDS, STAI, BDI II). Receives: Other: Quality of life in metastatic BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline quality of life during breast cancer treatment
quality of life assessed using QLQ-C30 Questionnaire
Measured: 3 years
Change from baseline psychological vulnerability during breast cancer treatment
Psychological vulnerability assessed using STAI questionnaire
Measured: 3 years
Change from baseline quality of life during breast cancer treatment
quality of life assessed using BR23 Questionnaire
Measured: 3 years
Change from baseline psychological vulnerability during breast cancer treatment
Psychological vulnerability assessed using Psychological distress scale. The scale represents a means of assessing the psychological state of patients. The scale measures 10 cm. The patients will have to put a cross on the line at the place which corresponds best to their psychological state of the past week. 0 indicates no distress and 10 very important distress.
Measured: 3 years
Change from baseline psychological vulnerability during breast cancer treatment
Psychological vulnerability assessed using BDI-II questionnaire
Measured: 3 years
Secondary outcomes (1)
number of therapeutic class treatment prescribed during breast cancer treatment
The therapeutic strategy is modified in case of progression: chemotherapy and/or hormonotherapy. This change in treatment can affect the quality of life and psychological vulnerability of patients. The number of therapeutic classes prescribed in this way will make it possible to describe their impact over time on patients' quality of life and psychological vulnerability.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start29 Dec 2016
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Why it stopped: The sponsor has set up a secondary competitive study concerning the same population and whose secondary objectives are the same as those of the EPOCA study with the same endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARIO CAMPONE, MD, Principal investigator, ICO NANTES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636776
- Sponsor's protocol ID
- ICO-N-2015-04
- Acronym
- EPOCA
- Status last verified
- Apr 2022
- First submitted
- 8 Aug 2018
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+
- ClinicalTrials.gov ID
- NCT03636776
- Acronym / sponsor ID
- EPOCA / ICO-N-2015-04
- Keywords
- Quality of Life, Psychological vulnerability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has set up a secondary competitive study concerning the same population and whose secondary objectives are the same as those of the EPOCA study with the same endpoints.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 17 Aug 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.
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.
However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :
- to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
- to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.
Detailed description
Studying quality of life over time in patients followed for metastatic breast cancer will identify when a person may feel most vulnerable in their experience of the disease and treatment. A specific and adapted support can thus be set up throughout the disease, from the diagnosis and during the different phases of treatment.
Patients will benefit from a longitudinal follow-up determined according to the treatments. For example :
Chemotherapy : After the first assessment time at 1 month from diagnosis, patients receiving chemotherapy treatment are seen every 3 months.
Hormone therapy : After the first assessment time at 1 month from diagnosis, patients receiving hormone therapy are seen every 2 months.
Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment.
The rhythm of the evaluation visits will therefore be defined by the doctor, according to the habits of the centre.
Patients will complete an end of study visit 3 years after inclusion
Quality of Life and Psychological vulnerability will be assessed through questionnaires :
- QLQ-C30 explores 5 functional scales (physical, social, psychological, cognitive functioning, daily activities) and 1 scale of health status and overall quality of life. It allows a detailed analysis of symptoms related to the disease and its treatment (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, sleep disturbance, constipation and diarrhea) as well as the financial impact for the patient.
- BR23 : specific questionnaire for breast cancer validated in French
- Psychological distress scale (PDS)
- State Trait Anxiety Inventory (STAI) : Assesses the feelings of apprehension, tension, nervousness and worry that the subject feels at the time of the anxiogenic or endangerment situation. This questionnaire is therefore an indicator of transient changes in anxiety caused by aversive or therapeutic situations.
- Beck Depression Inventory (BDI II) : assesses the severity of depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life in metastatic BC | Experimental | Other: Quality of life in metastatic BCPatients benefit from a longitudinal follow-up determined according to the treatments. Each type of treatment has its own schedule based on medical consultation times. At each change of treatment, from chemotherapy to hormone therapy or vice versa, the assessment times are determined according to the nature of the treatment. The rhythm of the evaluation visits will therefore be defined by the doctor, according to the habits of the centre. The evaluation times used to collect the questionnaires (QLQ-C30, BR23, PDS, STAI, BDI II). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed diagnosis of invasive breast cancer (=infiltrant). NB: Mixed histologies are allowed
- Adult women (≥ 18 years),
- Positive hormonal receptors (Estrogen receptors and/or Progesterone receptors ≥10%) and HER2 negative
- Patient in need of a 1st metastatic treatment line NB: Patients may have received prior treatment for their cancer, but not for their metastatic disease.
- Performance status ≤ 1 (world health organization)
Key exclusion criteria (7 listed)
- Patient with non-metastatic breast cancer,
- man
- Negative hormonal receptors or HER2 positive
- Psychiatric history with specialist diagnosis
- Pregnant or nursing patient
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 |
|---|---|---|
| Quality of life in metastatic BC1 month after metastatic stage diagnosis, patients complete their 1st therapeutic sequence evaluation visit (T1) within the recommended standard time frames. If the disease remains stable or if a response to treatment is observed then patients continue their follow-up in the same therapeutic sequence (T1). If progression occurs, treatment is modified and patients move on to the next therapeutic sequence (T2). And so on as many times as necessary. Before each evaluation visit with investigator, patients complete the questionnaires QLQ-C30, BR23, STAI, BDI II | Other | quality of life in metastatic BC |
Primary outcome
Change from baseline quality of life during breast cancer treatment
Time frame: 3 years
quality of life assessed using QLQ-C30 Questionnaire
Change from baseline psychological vulnerability during breast cancer treatment
Time frame: 3 years
Psychological vulnerability assessed using STAI questionnaire
Change from baseline quality of life during breast cancer treatment
Time frame: 3 years
quality of life assessed using BR23 Questionnaire
Change from baseline psychological vulnerability during breast cancer treatment
Time frame: 3 years
Psychological vulnerability assessed using Psychological distress scale. The scale represents a means of assessing the psychological state of patients. The scale measures 10 cm. The patients will have to put a cross on the line at the place which corresponds best to their psychological state of the past week. 0 indicates no distress and 10 very important distress.
Change from baseline psychological vulnerability during breast cancer treatment
Time frame: 3 years
Psychological vulnerability assessed using BDI-II questionnaire
1 secondary outcome
number of therapeutic class treatment prescribed during breast cancer treatment
Time frame: 3 years
Results and safety
The study was stopped early (reason given: The sponsor has set up a secondary competitive study concerning the same population and whose secondary objectives are the same as those of the EPOCA study with the same endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 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.
MARIO CAMPONE, MD principal investigator
ICO NANTES
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life in metastatic BC in people with Metastatic Breast Cancer and Positive Hormonal Receptors, run by Institut Cancerologie de l'Ouest at 2 sites 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The sponsor has set up a secondary competitive study concerning the same population and whose secondary objectives are the same as those of the EPOCA study with the same endpoints.). Results are not available in the source record.
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?
Change from baseline quality of life during breast cancer treatment (time frame: 3 years). The study lists 5 primary outcomes in all. 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 29 Dec 2022.