An observational study in Cancer and Sleep, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Observational
This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.
An accurate assessment of prognosis (life expectancy) is important for cancer patients, their carers, and their health care professionals. In the case of patients / their carers, it allows them to plan for the future, and to make more informed decisions about further anti-cancer treatments, and about referral to supportive and palliative care services. However, previous research suggests that health care professionals are not particularly good at estimating prognosis, and frequently over-estimate prognosis.
The aim of this project is to assess the usefulness of measuring physical activity, and differences between daytime and nighttime physical activity, in determining prognosis in patients with cancer. Studies suggest that these measures may be useful in determining prognosis in certain groups of patients with cancer (e.g. patients receiving chemotherapy for colon / rectum cancer). However, these studies need to be repeated in patients with different types of cancer, and also patients receiving other types of treatment (including supportive and palliative care). The aim of this small scale ("feasibility") study is to determine whether or not a large scale ("definitive") study can be done.
The feasibility study will include 50 patients with cancer, who will be asked to rate their performance status (physical activity) on a well-used scale, and then to wear a watch-like device for one week that measures physical activity and sleep patterns. The researcher will collect a blood sample: some of which will be used for analysis of parameters, which have previously been identified as prognostic indicators and will collect and store some blood for future transcriptome analysis. Participants will also be asked to complete a sleep diary during the week, and a questionnaire about their symptoms at the beginning and end of the week. The study will last one week in total and is collaboration between the Royal Surrey County Hospital, and the University of Surrey (Surrey Sleep Research Centre).
The number of participants in the feasibility study will be 50. Participants will be outpatients at the site, who meet all of the inclusion criteria and none of the exclusion criteria of the study (see above).
Exclusion Criteria:
Dichotomy Index (I<O)
Compares the amount of activity of the patient when in bed to when the patient is out of bed. An actigraphy-derived percentage of the activity counts, measured when the patient is in bed, that are inferior to (lower than) the median of the activity counts measured when the patient is out of bed.
Time frame: 7 days.
r24
An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours.
Time frame: upto 7 days
mean or average activity
calculated as the average number of wrist movements per minute throughout the recording time
Time frame: 7 days.
Actigraphy-derived sleep parameters
Parameters during the presumed sleep phase of the circadian cycle; eg: Time in bed, sleep efficiency e.t.c
Time frame: 7 days
Physician ECOG-PS
Physician's assessment of the patient's ECOG-Performance Status. The Eastern Cooperative Oncology Group performance scale (ECOG-PS) is a standardised measure for quantifying the functional status of patients with cancer and includes a numerical / categorical scale
Time frame: Day 0 actigraphy and Day 8 actigraphy
Patient ECOG-PS
Patient's assessment of their own ECOG-Performance Status
Time frame: Day 0 actigraphy and Day 8 actigraphy
Memorial Symptom Assessment Scale - Short Form (MSAS-SF)
The MSAS-SF is a validated symptom assessment tool that has been used extensively in oncology / palliative care research and includes questions on both physical and psychological symptoms.
Time frame: Day 0 actigraphy and Day 8 actigraphy
Pittsburgh Sleep Quality Index (PSQI)
This is a validated, self-rated questionnaire, which measures sleep quality and disturbances over a 1-month time period
Time frame: Day 8 actigraphy
Prognosis in Palliative Care Study predictor model (PiPS-B model)
Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators
Time frame: Day 0 actigraphy
modified Glasgow Prognostic Score (mGPS)
Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators
Time frame: Day 0 actigraphy
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Royal Surrey County Hospital NHS Foundation Trust