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

NCT03283683 | Completed DMC

• 1 other identifier: 16ONCN0004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Sleep

Keywords

rest-activity rhythm; survival; actigraphy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• r24

  upto 7 days

• mean or average activity

  7 days.

Other Outcomes (7)

• Actigraphy-derived sleep parameters

  7 days

• Physician ECOG-PS

  Day 0 actigraphy and Day 8 actigraphy

• Patient ECOG-PS

  Day 0 actigraphy and Day 8 actigraphy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

On first visit (Day 1 of the study), the researcher will collect total 7.5mls (1½ teaspoons) of blood from a vein in the participant's arm. 5 mL of the venous blood sample will be sent for analysis at the Royal Surrey County Hospital of haematological and biochemical parameters, i.e. white blood cell count (WBC), neutrophil count, lymphocyte count, platelet count, urea, alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin, C-reactive protein (CRP). 2.5 mL of the venous blood sample will be sent for bio-banking at the Surrey Clinical Research Centre at the University of Surrey (for future transcriptome analysis i.e. RNA analysis.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Derk-Jan Dijk

  Supervisor

  STUDY DIRECTOR

• Andrew Davies

  Supervisor

  STUDY DIRECTOR

• Shuchita D Patel

  PhD student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shuchita Dhwiren Patel

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 14, 2017
• Study Start: May 25, 2016
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)