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

NCT06662864 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Patients reported outcomes

Patients reported outcomes were collected via telephone

OTHER

questionnaire global Pittsburgh Sleep Quality Index (PSQI)

Patients reported outcomes were collected via telephone

Sponsors & Collaborators

  • Institut Rafael

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-08-31
Completion
2023-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06662864 on ClinicalTrials.gov