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

NCT ID: NCT03283683

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-25

Study Completion Date

2018-10-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shuchita Dhwiren Patel

Dr Shuchita Dhwiren Patel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Derk-Jan Dijk

Role: STUDY_DIRECTOR

Supervisor

Andrew Davies

Role: STUDY_DIRECTOR

Supervisor

Shuchita D Patel

Role: PRINCIPAL_INVESTIGATOR

PhD student

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16ONCN0004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SBRT or TACE for Advanced HCC
NCT03338647 UNKNOWN PHASE3