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PERSONAL - Sleep In Breast Cancer

Sponsor
Closed Loop Medicine (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05093426
Collaborator
(none)
285
Enrollment
1
Location
6.5
Anticipated Duration (Months)
44
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stage 2 Digital sleep diary app

Study Design

Study Type:
Observational
Anticipated Enrollment :
285 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Personalised Electronic Record Supported Two-Stage Observational Study of Sleep in Patients With Breast Cancer
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Insomnia in Breast cancer cohort

A single cohort will be observed in Stage 1 to assess the prevalence of insomnia suffered by participants who suffer from breast cancer. A subset of participants will continue to Stage 2 to use a digital sleep diary app for an observational period of 3 weeks.

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of insomnia in a cohort of breast cancer patients [3 weeks]

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

Secondary Outcome Measures

  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. [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. [3 weeks]

    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. [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. 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 [3 weeks]

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

  5. 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. [3 weeks]

    Assessment of insomnia prevalence, severity, and quality of life in subgroups based on clinical/treatment characteristics including breast cancer stage, treatment regime and baseline insomnia severity.

  6. Safety of the digital sleep diary [3 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christie NHS Foundation Trust Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Closed Loop Medicine

Investigators

  • Principal Investigator: Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons), Christie NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Closed Loop Medicine
ClinicalTrials.gov Identifier:
NCT05093426
Other Study ID Numbers:
  • CLM-INS-004
First Posted:
Oct 26, 2021
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Mar 28, 2022