Breast CancersNCT06662864
Study on Sleep, Lifestyle and Quality of Life in Women With Breast Cancer
An observational study of Breast Cancers, run by Institut Rafael at 1 site in France.
Trial summary
This was a prospective survey conducted at a single site, the Rafaël Institute, France. Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months. Patients reported outcomes were collected via telephone. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Breast Cancers
- What is being tested?
- Patients reported outcomes and questionnaire global Pittsburgh Sleep Quality Index (PSQI)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months.
Who may be able to join
- Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months
Who cannot join
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Sleep, Lifestyle and Quality of Life in Women With Breast Cancer Undergoing Endocrine Therapy
This was a prospective survey conducted at a single site, the Rafaël Institute, France. Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months. Patients reported outcomes were collected via telephone. Primary endpoint consisted in the global Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints included evaluation of anxiety and depression (hospital anxiety and depression scale, HADS), pain (numeric rating scale), health related quality of life (EQ-5D-5L) and lifestyle habits (questionnaire designed for this study). Descriptive statistical analyses were performed with the intention to treat population.
Sixty patients were included after providing oral informed consent. The PSQI evaluation of subjective sleep quality revealed a global score of 7.40. The majority of patients (73.3%) obtained a score > 5. Among those, 50% obtained a score between 6 and 10, while 23.3% had a score between 11 and 15. In contrast, only 26.7% of patients were good sleepers with a score <=5. Mean scores for anxiety and depression were 6.5 (+/- 3.8) and 3.3 (+/- 3.2) indicating non cases. The majority of patients (44; 73%) said to suffer from joint pain. In a matrix correlation test, the correlation index of PSQI with anxiety, depression and pain were +0.19, +0.28 and +0.44, respectively. The mean score in the EQ-5D-5L visual analogue scale was 63.0 (+/-13) for the entire sample. 44% of patients reported to use complementary medicine to help them feel better.
The majority of patients with breast cancer undergoing endocrine therapy were considered poor sleepers. Pain was moderately correlated with sleep disorders while both anxiety and depression showed a weak correlation. Awareness and knowledge on integrative approaches to support and improve patients' outcomes remains low among breast cancer patients.
Read the detailed description
Adjuvant therapy with either tamoxifen or aromatase inhibitors reduces breast cancer recurrence and improves overall survival in patients with hormone receptor-positive breast cancer. However, the benefits achieved with adjuvant endocrine therapy come at a cost. A variety of negative symptoms can substantially impair patients' quality of life and treatment adherence. Sleep disorder, a well-known side effect of endocrine therapy, may compromise treatment effectiveness and serves as relevant behavioral marker of poor prognosis. In order to be able to offer personalized solutions combining conventional pharmacological medicine with non-pharmacological approaches, it is important to understand the impact of the sleep disorders particularly in women with breast cancer on endocrine therapy who present an increased risk of insomnia. The primary aim of this study was to assess sleep quality and its relationship with anxiety, depression and pain. Patients' lifestyle, knowledge on integrative approaches to health and global quality of life were also evaluated.
- Conditions
- Breast Cancers
- Being tested
- Patients reported outcomes, questionnaire global Pittsburgh Sleep Quality Index (PSQI)
- Keywords
- breast cancer, endocrine therapy, Quality of Life, anxiety and depression, integrative medecine, sleep disorders
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients reported outcomesOther
Also called survey, questionnaires
Patients reported outcomes were collected via telephone
questionnaire global Pittsburgh Sleep Quality Index (PSQI)Other
Patients reported outcomes were collected via telephone
| Study group | Role | What they receive |
|---|---|---|
| patients | women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer Receives: Other: Patients reported outcomes; Other: questionnaire global Pittsburgh Sleep Quality Index (PSQI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire Pittsburgh Sleep Quality Index (PSQI)
The PSQI comprises 19 self-rated questions grouped into 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction). Each component score weighs equally on a 0 (no difficulty) to 3 (severe difficulty). The scores of 7 components are summed up to a global PSQI score, which ranged from 0 to 21 points with a cutoff score of ≤ 5 indicating good sleep quality.
Measured: 30 minutes
Secondary outcomes (4)
hospital anxiety and depression scale, HADS
HADS consisted of 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. The answer format offers four response options, which are scored with values ranging from 0 to 3. This results in scale values between 0 and 21 for each scale. The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases).
Measured: 30 minutes
pain scale (numeric rating scale)
numeric rating scale of 0 to 10 where zero means "no pain" and ten means "the worst possible pain"
Measured: 30 minutes
questionnaire health related quality of life EQ-5D-5L
The EQ-5D-5L score is presented between 0 (worst imaginable health) and 100 (best imaginable health) for their current overall health-related quality of life.
Measured: 30 minutes
questionnaire lifestyle habits
Questions designed for this study
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jun 2023
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Rafael
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662864
- Sponsor's protocol ID
- IR-2024-002
- Other IDs
- 2024-A01086-41
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Sleep, Lifestyle and Quality of Life in Women With Breast Cancer Undergoing Endocrine Therapy
- ClinicalTrials.gov ID
- NCT06662864
- Acronym / sponsor ID
- IR-2024-002
- Conditions
- Breast Cancers
- Keywords
- breast cancer, endocrine therapy, Quality of Life, anxiety and depression, integrative medecine, sleep disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut RafaelUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Oct 2024 (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.
This was a prospective survey conducted at a single site, the Rafaël Institute, France. Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months. Patients reported outcomes were collected via telephone. Primary endpoint consisted in the global Pittsburgh Sleep Quality Index (PSQI). Secondary endpoints included evaluation of anxiety and depression (hospital anxiety and depression scale, HADS), pain (numeric rating scale), health related quality of life (EQ-5D-5L) and lifestyle habits (questionnaire designed for this study). Descriptive statistical analyses were performed with the intention to treat population.
Sixty patients were included after providing oral informed consent. The PSQI evaluation of subjective sleep quality revealed a global score of 7.40. The majority of patients (73.3%) obtained a score > 5. Among those, 50% obtained a score between 6 and 10, while 23.3% had a score between 11 and 15. In contrast, only 26.7% of patients were good sleepers with a score <=5. Mean scores for anxiety and depression were 6.5 (+/- 3.8) and 3.3 (+/- 3.2) indicating non cases. The majority of patients (44; 73%) said to suffer from joint pain. In a matrix correlation test, the correlation index of PSQI with anxiety, depression and pain were +0.19, +0.28 and +0.44, respectively. The mean score in the EQ-5D-5L visual analogue scale was 63.0 (+/-13) for the entire sample. 44% of patients reported to use complementary medicine to help them feel better.
The majority of patients with breast cancer undergoing endocrine therapy were considered poor sleepers. Pain was moderately correlated with sleep disorders while both anxiety and depression showed a weak correlation. Awareness and knowledge on integrative approaches to support and improve patients' outcomes remains low among breast cancer patients.
Detailed description
Adjuvant therapy with either tamoxifen or aromatase inhibitors reduces breast cancer recurrence and improves overall survival in patients with hormone receptor-positive breast cancer. However, the benefits achieved with adjuvant endocrine therapy come at a cost. A variety of negative symptoms can substantially impair patients' quality of life and treatment adherence. Sleep disorder, a well-known side effect of endocrine therapy, may compromise treatment effectiveness and serves as relevant behavioral marker of poor prognosis. In order to be able to offer personalized solutions combining conventional pharmacological medicine with non-pharmacological approaches, it is important to understand the impact of the sleep disorders particularly in women with breast cancer on endocrine therapy who present an increased risk of insomnia. The primary aim of this study was to assess sleep quality and its relationship with anxiety, depression and pain. Patients' lifestyle, knowledge on integrative approaches to health and global quality of life were also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Other: Patients reported outcomes, Other: questionnaire global Pittsburgh Sleep Quality Index (PSQI)women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months.
Key inclusion criteria (1 listed)
- Eligible patients were women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer and undergoing adjuvant endocrine therapy since at least 3 months
Key exclusion criteria (1 listed)
- less than 18 years old
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 |
|---|---|---|
| Patients reported outcomesAlso: survey, questionnairesPatients reported outcomes were collected via telephone | Other | patients |
| questionnaire global Pittsburgh Sleep Quality Index (PSQI)Patients reported outcomes were collected via telephone | Other | patients |
Primary outcome
questionnaire Pittsburgh Sleep Quality Index (PSQI)
Time frame: 30 minutes
The PSQI comprises 19 self-rated questions grouped into 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction). Each component score weighs equally on a 0 (no difficulty) to 3 (severe difficulty). The scores of 7 components are summed up to a global PSQI score, which ranged from 0 to 21 points with a cutoff score of ≤ 5 indicating good sleep quality.
4 secondary outcomes
hospital anxiety and depression scale, HADS
Time frame: 30 minutes
pain scale (numeric rating scale)
Time frame: 30 minutes
questionnaire health related quality of life EQ-5D-5L
Time frame: 30 minutes
questionnaire lifestyle habits
Time frame: 30 minutes
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 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancers, run by Institut Rafael 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 1 inclusion and 1 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 30 Oct 2024. 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?
questionnaire Pittsburgh Sleep Quality Index (PSQI) (time frame: 30 minutes). 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 30 Oct 2024.