CancerAIPACaNCT03283683
A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer
An observational study of Cancer and Sleep, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2016to 19 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
About this study
This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.
Read the 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).
- Keywords
- rest-activity rhythm, survival, actigraphy
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days.
Secondary outcomes (2)
r24
An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours.
Measured: upto 7 days
mean or average activity
calculated as the average number of wrist movements per minute throughout the recording time
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start25 May 2016
- Primary completion19 Oct 2017
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuchita Dhwiren Patel, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Derk-Jan Dijk, Study director, SupervisorAndrew Davies, Study director, SupervisorShuchita D Patel, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283683
- Sponsor's protocol ID
- 16ONCN0004
- Acronym
- AIPACa
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03283683
- Acronym / sponsor ID
- AIPACa / 16ONCN0004
- Keywords
- rest-activity rhythm, survival, actigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 19 Oct 2017 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Outpatients.
- Age ≥ 18 years.
- Diagnosis of locally advanced / metastatic cancer.
- No curative treatment available.
- Patient receiving supportive and palliative care.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dichotomy Index (I<O)
Time frame: 7 days.
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.
2 secondary outcomes
r24
Time frame: upto 7 days
mean or average activity
Time frame: 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derk-Jan Dijk study director
Supervisor
Andrew Davies study director
Supervisor
Shuchita D Patel principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Sleep, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dichotomy Index (I<O) (time frame: 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.