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NCT Number: NCT05093426

PERSONAL - Sleep In Breast Cancer

Sleep is essential for human function, immunity, and well-being. In the general population, sleep disturbance and insomnia cause significant health problems and impact on the quality of life of many individuals. The incidence of insomnia in cancer patients is disproportionality higher, with breast cancer patients experiencing prevalence rates ranging from 19% to 69%. The impact of insomnia on cancer patients' lives can be significant and is associated with depression, cancer-related fatigue, increased pain, reduced quality of life, decreased immunity, disease progression, and survival. To date, breast cancer studies show large variation in reported insomnia prevalence rates, and the severity of sleep complaints in these patients have been difficult to assess. Thus, these issues require further investigation using standardised and validated measures.

In this observational study, we aim to investigate the prevalence and severity of insomnia in a cohort of breast cancer patients at the Christie Hospital using the Insomnia Severity Index (ISI), a validated measure for insomnia. This study will consist of two stages. In Stage 1, patients aged 18 and over, who provide informed consent and have a diagnosis of Stage I, II or III breast cancer in the previous 12 months will be asked to complete the validated ISI. Using the ISI, participants identified as having sleeping difficulties and/or insomnia will be invited to Stage 2 of the study. In this stage, participants will be asked to track their sleep each morning for 3 weeks using a digital sleep diary downloaded onto their own smartphone. They will also be asked to complete a series of questionnaires gathering information regarding their quality of life, well-being, and health. This research will provide a better understanding of sleeping patterns, sleeping difficulties and insomnia in patients with breast cancer, and in the long-term, help us design better treatments for patients with sleeping problems.

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Key information

Conditions

Insomnia Breast Cancer Breast Diseases Breast Neoplasms Dyssomnias Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Stage 1:

  • Age > 18 years.
  • Informed consent to Stage 1 of the study
  • Diagnosis of Stage I, II or III breast cancer within the previous 12 months

Stage 2:

  • Informed consent to Stage 2 of the study
  • Current Sleep Disturbance; a score of 8 or more on the Insomnia Severity Index.
  • History of sleep disturbance prior to the screening/baseline consultation; with beginning or worsening of sleep disturbance since breast cancer diagnosis e.g. sleep problems began or get worse with the diagnosis of breast cancer or with chemotherapy.
  • Possession of a suitable smartphone that participant can use independently.

Exclusion criteria

Stage 1:

  • Participants who have limited or no understanding of spoken and/or written English.
  • Other diagnosis of cancer, not including basal cell carcinoma of the skin or cervical carcinoma in situ, within the previous 5 years

Stage 2:

  • Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smartphone.
  • Known and/or treated sleep apnoea
  • Regular shift work or night work (defined as >1 overnight shift per month)
  • Breast feeding

Treatment and study plan

Stage 2 Digital sleep diary app

Other

Participants in Stage 2 will be asked to download a digital sleep diary app and complete a sleep log every day for 21 days.

Primary outcomes

  1. Prevalence of Insomnia in a Cohort of Breast Cancer Patients

    Time frame: 3 weeks

    Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index

Secondary outcomes

  1. In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Insomnia Severity Over a Three-week Period.

    Time frame: 2 weeks

    Insomnia severity using Insomnia Severity Index (min. 0, max. 28 where higher scores mean a worse outcome). With severity classified by total score for the Insomnia Severity Index: 0-7 no significant insomnia, 8-14 Subthreshold insomnia, 15-21 Clinical insomnia (moderate severity) and 22-28 Clinical Insomnia (Severe severity)

  2. In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Sleep Efficiency Over a Three-week Period.

    Time frame: 3 weeks

    In patients with breast cancer experiencing insomnia (defined as score of 8 or more on the Insomnia Severity Index; ISI scale), to assess Sleep efficiency over a three-week period. Sleep efficiency (the % of time a participant is asleep whilst in bed) measured using Sleep diary (derived from total time asleep relative to total time in bed).

  3. In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.

    Time frame: 3 weeks

    Quality of Life using EQ-5D-5L questionnaire (multiple choice questions regarding Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression as well as measure of % of health using scale where higher percentage is greater outcome) and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaire (questions regarding Physical well-being, Social/Family well-being, Emotional, Functional well-being and Additional concerns using scale of 0 - 4 where 0 is Not at all, 1 is A little bit, 2 is Some-what, 3 is Quite a bit and 4 is Very much).

  4. In Patients With Breast Cancer Experiencing Insomnia (Defined as Score of 8 or More on the Insomnia Severity Index; ISI Scale), to Assess Quality of Life Over a Three-week Period.

    Time frame: 3 weeks

    EQ-5D-5L questionnaire: multiple choice questions for Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety/Depression and % of health where a higher % is a greater outcome). Functional Assessment of Cancer Therapy - Endocrine Systems (FACT-ES) (sub-scales: Physical well-being, Social/Family well-being, Emotional, Functional well-being and Endocrine symptoms): each question in sub-scales are scored using a scale of 0-4 where 0 is Not at all, 1 is A little bit, 2 is Some-what, 3 is Quite a bit and 4 is Very much. Scores for questions are added to give total baseline and total day 21 score for each sub-scale. Minimum total score is 0 for all sub-scales, the maximum scores are 28 for Physical, Social/Family and Functional well-being sub-scales, 24 for the Emotional well-being sub-scale, 76 for Endocrine symptoms. A lower total score represents better outcomes. FACT-ES = Total of subscale scores (0-184). FACT-G = Total of subscale scores excluding endocrine system (0-108).

  5. To Assess: - Compliance of Data Entry Into the Digital Sleep Diary - Feasibility and Experience of Patients to Input Data Relating to Their Sleep Into a Mobile Phone Application Daily

    Time frame: 3 weeks

    Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire.

  6. Associations Between Insomnia Prevalence and Severity as Measured by the Insomnia Severity Index and Quality of Life (EQ-5D-5L and FACT-ES) With Clinical or Treatment Characteristics of Breast Cancer Patients.

    Time frame: 3 weeks

    Assessment to determine if there is any association or correlation between insomnia prevalence and severity as well as quality of life (using insomnia severity index and EQ-5D-5L and Functional Assessment of Cancer Therapy - Endocrine Systems questionnaires) for patients in subgroups based on clinical or treatment characteristics i.e. breast cancer stage (Stage I, II or III), tumour staging (T1, T2, T3 or DCIS) treatment regimen (Systemic treatment, Dexamethasone treatment, Radiation therapy, Hormonal or Targeted Therapy as well as time since start of chemotherapy and current systemic anti-cancer therapy).

  7. Safety of the Digital Sleep Diary

    Time frame: 3 weeks

    Adverse Events and Serious Adverse Events will be collected and summarised.

Sponsors and collaborators

Lead sponsor

Closed Loop Medicine

Industry

Registry information

Official study title

Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With Breast Cancer

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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