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

NCT06662864 | Completed

• 2 other identifiers: IR-2024-0022024-A01086-41
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancers

Keywords

breast cancer; endocrine therapy; Quality of Life; anxiety and depression; integrative medecine; sleep disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes

Secondary Outcomes (4)

• 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

Study Arms (1)

patients

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

Other: Patients reported outcomes; Other: questionnaire global Pittsburgh Sleep Quality Index (PSQI)

Interventions

Patients reported outcomes OTHER

Patients reported outcomes were collected via telephone

Also known as: survey, questionnaires

patients

questionnaire global Pittsburgh Sleep Quality Index (PSQI) OTHER

Patients reported outcomes were collected via telephone

patients

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• less than 18 years old

Sponsors & Collaborators

• Institut Rafael: lead

Study Sites (1)

Institute Rafaël

Levallois-Perret, Institut Rafael, 92300, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression; Sleep Wake Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 29, 2024
• Study Start: June 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)