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

This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.

Study Overview

• Status: Completed
• Conditions: Cancer; Sleep

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).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Royal Surrey County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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).

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy-derived sleep parameters	Parameters during the presumed sleep phase of the circadian cycle; eg: Time in bed, sleep efficiency e.t.c	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	Day 0 actigraphy and Day 8 actigraphy
Patient ECOG-PS	Patient's assessment of their own ECOG-Performance Status	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.	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	Day 8 actigraphy
Prognosis in Palliative Care Study predictor model (PiPS-B model)	Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators	Day 0 actigraphy
modified Glasgow Prognostic Score (mGPS)	Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators	Day 0 actigraphy

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Study Director: Derk-Jan Dijk, Supervisor; Study Director: Andrew Davies, Supervisor; Principal Investigator: Shuchita D Patel, PhD student

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2016
• Primary Completion (Actual): October 19, 2017
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: survival; actigraphy; rest-activity rhythm
• Other Study ID Numbers: 16ONCN0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No