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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Insomnia in a Cohort of Breast Cancer Patients | Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Not provided
Inclusion Criteria
Stage 1:
Stage 2:
Exclusion Criteria:
Stage 1:
Stage 2:
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A cohort of patients diagnosed with breast cancer in the United Kingdom.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Armstrong, PhD, MRCP, MBChB, BSc(Hons) | Christie NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31855038 | Background | Ruel S, Ivers H, Savard MH, Gouin JP, Lemieux J, Provencher L, Caplette-Gingras A, Bastien C, Morin CM, Couture F, Savard J. Insomnia, immunity, and infections in cancer patients: Results from a longitudinal study. Health Psychol. 2020 May;39(5):358-369. doi: 10.1037/hea0000811. Epub 2019 Dec 19. | |
| 32314110 | Background |
| Label | URL |
|---|---|
| Epidemiology of Insomnia - Prevalence, Course, Risk Factors, and Public Health Burden | View source |
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To be confirmed whether the individual participant data will be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
| |||||||||||||
| Stage 2 |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 2 missing values |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of Insomnia in a Cohort of Breast Cancer Patients | Percentage of breast cancer patients scoring 8 or above on the Insomnia Severity Index | Posted | Count of Participants | Participants | 3 weeks |
|
|
3 weeks
Nurses called participants at the end of the 3-week period to ask if they had experienced any adverse events during the 3-week period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nihal Noori | Closed Loop Medicine Ltd. | 07443603405 | nihal.noori@closedloopmedicine.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2021 | Sep 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 9, 2022 | Sep 27, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| 2 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. | 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 weeks |
| 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. | 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). | 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 Quality of Life Over a Three-week Period. | 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). | 3 weeks |
| 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 | Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire. | 3 weeks |
| 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. | 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). | 3 weeks |
| Safety of the Digital Sleep Diary | Adverse Events and Serious Adverse Events will be collected and summarised. | 3 weeks |
| Kwak A, Jacobs J, Haggett D, Jimenez R, Peppercorn J. Evaluation and management of insomnia in women with breast cancer. Breast Cancer Res Treat. 2020 Jun;181(2):269-277. doi: 10.1007/s10549-020-05635-0. Epub 2020 Apr 20. |
| 30521041 | Background | Fleming L, Randell K, Stewart E, Espie CA, Morrison DS, Lawless C, Paul J. Insomnia in breast cancer: a prospective observational study. Sleep. 2019 Mar 1;42(3):zsy245. doi: 10.1093/sleep/zsy245. |
| 28623402 | Background | Fontes F, Pereira S, Costa AR, Goncalves M, Lunet N. The impact of breast cancer treatments on sleep quality 1 year after cancer diagnosis. Support Care Cancer. 2017 Nov;25(11):3529-3536. doi: 10.1007/s00520-017-3777-6. Epub 2017 Jun 16. |
| 12547047 | Background | Fortner BV, Stepanski EJ, Wang SC, Kasprowicz S, Durrence HH. Sleep and quality of life in breast cancer patients. J Pain Symptom Manage. 2002 Nov;24(5):471-80. doi: 10.1016/s0885-3924(02)00500-6. |
| 33631331 | Background | Hajj A, Hachem R, Khoury R, Nehme T, Hallit S, Nasr F, Karak FE, Chahine G, Kattan J, Khabbaz LR. Clinical and Genetic Factors Associated With the Breast Cancer-Related Sleep Disorders: The "CAGE-Sleep" Study-A Cross-Sectional Study. J Pain Symptom Manage. 2021 Sep;62(3):e46-e55. doi: 10.1016/j.jpainsymman.2021.02.022. Epub 2021 Feb 22. |
| 21825267 | Background | Savard J, Ivers H, Villa J, Caplette-Gingras A, Morin CM. Natural course of insomnia comorbid with cancer: an 18-month longitudinal study. J Clin Oncol. 2011 Sep 10;29(26):3580-6. doi: 10.1200/JCO.2010.33.2247. Epub 2011 Aug 8. |
| 33093806 | Background | Brzecka A, Sarul K, Dyla T, Avila-Rodriguez M, Cabezas-Perez R, Chubarev VN, Minyaeva NN, Klochkov SG, Neganova ME, Mikhaleva LM, Somasundaram SG, Kirkland CE, Tarasov VV, Aliev G. The Association of Sleep Disorders, Obesity and Sleep-Related Hypoxia with Cancer. Curr Genomics. 2020 Sep;21(6):444-453. doi: 10.2174/1389202921999200403151720. |
| 24790261 | Background | Palesh O, Aldridge-Gerry A, Zeitzer JM, Koopman C, Neri E, Giese-Davis J, Jo B, Kraemer H, Nouriani B, Spiegel D. Actigraphy-measured sleep disruption as a predictor of survival among women with advanced breast cancer. Sleep. 2014 May 1;37(5):837-42. doi: 10.5665/sleep.3642. |
| 11157043 | Background | Savard J, Morin CM. Insomnia in the context of cancer: a review of a neglected problem. J Clin Oncol. 2001 Feb 1;19(3):895-908. doi: 10.1200/JCO.2001.19.3.895. |
| 31873040 | Background | Marion LP, Ivers H, Savard J. Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy. Behav Sleep Med. 2021 Jan-Feb;19(1):70-82. doi: 10.1080/15402002.2019.1707203. Epub 2019 Dec 24. |
| 15675652 | Background | O'Donnell JF. Insomnia in cancer patients. Clin Cornerstone. 2004;6 Suppl 1D:S6-14. doi: 10.1016/s1098-3597(05)80002-x. |
| 11438246 | Background | Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. |
| 22294820 | Background | Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642. |
| 28400355 | Background | Horsch CH, Lancee J, Griffioen-Both F, Spruit S, Fitrianie S, Neerincx MA, Beun RJ, Brinkman WP. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. J Med Internet Res. 2017 Apr 11;19(4):e70. doi: 10.2196/jmir.6524. |
| 28162145 | Background | Kang SG, Kang JM, Cho SJ, Ko KP, Lee YJ, Lee HJ, Kim L, Winkelman JW. Cognitive Behavioral Therapy Using a Mobile Application Synchronizable With Wearable Devices for Insomnia Treatment: A Pilot Study. J Clin Sleep Med. 2017 Apr 15;13(4):633-640. doi: 10.5664/jcsm.6564. |
| 21479777 | Background | Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. |
| 10481946 | Background | Fallowfield LJ, Leaity SK, Howell A, Benson S, Cella D. Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B. Breast Cancer Res Treat. 1999 May;55(2):189-99. doi: 10.1023/a:1006263818115. |
| Insomnia in breast cancer: prevalence and associated factors | View source |
| Empirical validation of the Insomnia Severity Index in cancer patients | View source |
| Disruption of sleep, sleep-wake activity rhythm, and nocturnal melatonin production in breast cancer patients undergoing adjuvant chemotherapy: a prospective cohort study | View source |
| Joint statement on seeking consent by electronic methods | View source |
| Consent and Participant Information Guidance | View source |
| Sample Size Calculator for Estimating a Single Proportion | View source |
| Construction and Evaluation of a User Experience Questionnaire | View source |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 2 missing values | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | 2 missing values | Count of Participants | Participants | No |
|
| Smartphone access | 2 missing values | Count of Participants | Participants | No |
|
| Weight (kg) | 2 missing values | Mean | Standard Deviation | kg |
|
| Height (cm) | 2 missing values | Mean | Standard Deviation | cm |
|
| Body Mass Index (kg/m^2) | 2 missing values | Count of Participants | Participants | No |
|
| Breastfeeding | 2 missing values | Count of Participants | Participants | No |
|
| Regular night-work/shift work | 2 missing values | Count of Participants | Participants | No |
|
| Marital status | 2 missing values | Count of Participants | Participants | No |
|
| Education level | 2 missing values | Count of Participants | Participants | No |
|
| Employment status | 2 missing values | Count of Participants | Participants | No |
|
| Menopausal status | 2 missing values | Count of Participants | Participants | No |
|
| Sleep difficulties | 2 missing values | Count of Participants | Participants | No |
|
| Sleep difficulties started/worsened since diagnosis | 16 missing values | Count of Participants | Participants | No |
|
| Prescribed medication for sleep issues | 52 missing values | Count of Participants | Participants | No |
|
| Sleep apnoea | 2 missing values | Count of Participants | Participants | No |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | 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) | Posted | Count of Participants | Participants | No | 2 weeks |
|
|
|
| Secondary | 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. | 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). | Posted | Mean | Standard Deviation | percentage of time participant is asleep | 3 weeks |
|
|
|
| Secondary | 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. | 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). | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| Secondary | 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. | 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). | 7 missing values at Day 21 | Posted | Mean | Standard Deviation | score on a scale | 3 weeks |
|
|
|
| Secondary | 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 | Compliance; % of patients completing sleep diary (17 or more days out of 21) Feasibility and User experience; User experience questionnaire. | Number of subjects completing the digital sleep diary on at least 17 out of 21 days | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| Secondary | 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. | 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). | These are descriptions of the subgroups that were analysed based on breast cancer stage, tumour staging and treatment regimen therefore the reported numbers reflect the number of participants in each subgroup. | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| Secondary | Safety of the Digital Sleep Diary | Adverse Events and Serious Adverse Events will be collected and summarised. | Posted | Number | participants | No | 3 weeks |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 51 |
| 105 |
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Itchy skin on arms | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stinging on left axilla scar | Nervous system disorders | Systematic Assessment |
|
| Covid-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Hot flashes | Vascular disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Mood changes | Psychiatric disorders | Systematic Assessment |
|
| Sleep struggles | Psychiatric disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Low mood | Psychiatric disorders | Systematic Assessment |
|
| Neuropathy in the tips fingers and soles | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sore skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Dizzy spells | Nervous system disorders | Systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Migraines | Nervous system disorders | Systematic Assessment |
|
| Blisters | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Discomfort | General disorders | Systematic Assessment |
|
| Discomfort on palpation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Pain around radiotherapy site | General disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Edema - hands and feet | General disorders | Systematic Assessment |
|
| Joint ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Radiating arm pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intermittent pain | General disorders | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | Systematic Assessment |
|
| Cold sore | Infections and infestations | Systematic Assessment |
|
| Aching legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Aching joints | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Clinical insomnia (severe) |
|
| EQ-5D-5L - Mobility - Day 21 |
|
| EQ-5D-5L - Self-care - Baseline |
|
| EQ-5D-5L - Self-care - Day 21 |
|
| EQ-5D-5L - Usual activities - Baseline |
|
| EQ-5D-5L - Usual activities - Day 21 |
|
| EQ-5D-5L - Pain/discomfort - Baseline |
|
| EQ-5D-5L - Pain/discomfort - Day 21 |
|
| EQ-5D-5L - Anxiety/depression - Baseline |
|
| EQ-5D-5L - Anxiety/depression - Day 21 |
|
|
| FACT-ES - Social/family well-being - Total Baseline score |
|
|
| FACT-ES - Social/family well-being - Total Day 21 score |
|
|
| FACT-ES - Emotional well-being - Total Baseline score |
|
|
| FACT-ES - Emotional well-being - Total Day 21 score |
|
|
| FACT-ES - Functional well-being - Total Baseline score |
|
|
| FACT-ES - Functional well-being - Total Day 21 score |
|
|
| FACT-ES - Endocrine Symptom Subscale - Total Baseline score |
|
|
| FACT-ES - Endocrine Symptom Subscale - Total Day 21 score |
|
|
| FACT-ES - Total Baseline score |
|
|
| FACT-ES - Total Day 21 score |
|
|
| FACT-G - Total Baseline score |
|
|
| FACT-G - Total Day 21 score |
|
|
|
| Stage III breast cancer participants who reported as having insomnia (ISI score 8 or above) |
|
|
| Stage I breast cancer participants who reported as having subthreshold insomnia |
|
|
| Stage I breast cancer participants who reported as having clinical insomnia (moderate severity) |
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| Stage I breast cancer participants who reported as having clinical insomnia (severe) |
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| Stage II breast cancer participants who reported as having subthreshold insomnia |
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| Stage II breast cancer participants who reported as having clinical insomnia (moderate severity) |
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| Stage II breast cancer participants who reported as having clinical insomnia (severe) |
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| Stage III breast cancer participants who reported as having subthreshold insomnia |
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| Stage III breast cancer participants who reported as having clinical insomnia (moderate severity) |
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| Stage III breast cancer participants who reported as having clinical insomnia (severe) |
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| Tumour staging T1 participants who reported as having insomnia (ISI score 8 or above) |
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| Tumour staging T2 participants who reported as having insomnia (ISI score 8 or above) |
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| Tumour staging T3 participants who reported as having insomnia (ISI score 8 or above) |
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| Tumour staging DCIS participants who reported as having insomnia (ISI score 8 or above) |
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| Systemic anti-cancer therapy participants who reported as having insomnia (ISI score 8 or above) |
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| Dexamethasone treatment participants who reported as having insomnia (ISI score 8 or above) |
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| Radiation therapy participants who reported as having insomnia (ISI score 8 or above) |
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| Targeted therapy participants who reported as having insomnia (ISI score 8 or above) |
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| Hormonal treatment participants who reported as having insomnia (ISI score 8 or above) |
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