Cancer Clinical Trial
— AIPACaOfficial title:
A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer
NCT number | NCT03283683 |
Other study ID # | 16ONCN0004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2016 |
Est. completion date | October 19, 2018 |
Verified date | March 2019 |
Source | Royal Surrey County Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the use of actigraphy-derived measures to improve prognostication in patients with advanced cancer.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 19, 2018 |
Est. primary completion date | October 19, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Surrey County Hospital | Guildford | Surrey |
Lead Sponsor | Collaborator |
---|---|
Royal Surrey County Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | Patient ECOG-PS | Patient's assessment of their own ECOG-Performance Status | Day 0 actigraphy and Day 8 actigraphy | |
Other | 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 | |
Other | 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 | |
Other | Prognosis in Palliative Care Study predictor model (PiPS-B model) | Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators | Day 0 actigraphy | |
Other | modified Glasgow Prognostic Score (mGPS) | Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators | Day 0 actigraphy | |
Primary | 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 | r24 | An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours. | upto 7 days | |
Secondary | mean or average activity | calculated as the average number of wrist movements per minute throughout the recording time | 7 days. |
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