Study on Sleep, Lifestyle and Quality of Life in Women With Breast Cancer Undergoing Endocrine Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- questionnaire Pittsburgh Sleep Quality Index (PSQI)
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •less than 18 years old
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- hospital anxiety and depression scale, HADS(30 minutes)
- pain scale (numeric rating scale)(30 minutes)
- questionnaire health related quality of life EQ-5D-5L(30 minutes)
- questionnaire lifestyle habits(30 minutes)