A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer

Study Overview
=================
Brief Summary
-----------------
This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.

Detailed Description
-----------------
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).

Official Title
-----------------
A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer

Conditions
-----------------
Cancer, Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients. Age ≥ 18 years. Diagnosis of locally advanced / metastatic cancer. No curative treatment available. Patient receiving supportive and palliative care. Negative response from palliative medicine physician to the surprise question (i.e. would you be surprised if this patient were to die in the next 12 months). (Estimated) prognosis of > 2 weeks. Exclusion Criteria: Inpatients. Age < 18 years. Diagnosis of local (non-advanced) cancer. Curative treatment available. Presence of a physical disability that affects daytime activity (e.g. metastatic spinal cord compression). Presence of a physical disability that affects movement of the non-dominant arm (e.g. lymphoedema). Cognitive impairment (clinical judgement).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| r24 | An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours. | upto 7 days | 
| mean or average activity | calculated as the average number of wrist movements per minute throughout the recording time | 7 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rest-activity rhythm, survival, actigraphy