Study on Sleep, Lifestyle and Quality of Life in Women With Breast Cancer

NCT ID: NCT06662864

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-31

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.

Conditions

Breast Cancers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

patients

women aged 20 to 85 years old diagnosed with hormone receptor positive breast cancer

Patients reported outcomes

Intervention Type: OTHER

Patients reported outcomes were collected via telephone

questionnaire global Pittsburgh Sleep Quality Index (PSQI)

Intervention Type: OTHER

Patients reported outcomes were collected via telephone

Interventions

Patients reported outcomes

Patients reported outcomes were collected via telephone

Intervention Type: OTHER

questionnaire global Pittsburgh Sleep Quality Index (PSQI)

Patients reported outcomes were collected via telephone

Intervention Type: OTHER

Other Intervention Names

survey; questionnaires

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Rafael

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute Rafaël

Levallois-Perret, Institut Rafael, France

Countries

France

Other Identifiers

2024-A01086-41

Identifier Type: OTHER

Identifier Source: secondary_id

IR-2024-002

Identifier Type: -

Identifier Source: org_study_id