Clinical trial NCT03283683: A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer
Official title: A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Sleep
Keywords: rest-activity rhythm
survival
actigraphy
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

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).

Primary outcomes:
measure: Dichotomy Index (I<O)
timeFrame: 7 days.
Secondary outcomes:
measure: r24
timeFrame: upto 7 days
measure: mean or average activity
timeFrame: 7 days.
Other outcomes:
measure: Actigraphy-derived sleep parameters
timeFrame: 7 days
measure: Physician ECOG-PS
timeFrame: Day 0 actigraphy and Day 8 actigraphy
measure: Patient ECOG-PS
timeFrame: Day 0 actigraphy and Day 8 actigraphy
measure: Memorial Symptom Assessment Scale - Short Form (MSAS-SF)
timeFrame: Day 0 actigraphy and Day 8 actigraphy
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Day 8 actigraphy
measure: Prognosis in Palliative Care Study predictor model (PiPS-B model)
timeFrame: Day 0 actigraphy
measure: modified Glasgow Prognostic Score (mGPS)
timeFrame: Day 0 actigraphy
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
Study officials:
affiliation: Supervisor
name: Derk-Jan Dijk
role: STUDY_DIRECTOR
affiliation: Supervisor
name: Andrew Davies
role: STUDY_DIRECTOR
affiliation: PhD student
name: Shuchita D Patel
role: PRINCIPAL_INVESTIGATOR
References: