Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria |
Assessing the sensitivity and specificity of the screening tool |
Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer |
Assessing the correlation between scores from the screening tool at two time points |
Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer |
Patient ease of use, understandability, acceptability and time to complete. |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer |
Patient ease of use, understandability, and acceptability |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer |
Incidence of Circadian rest-Activity Rhythm Disorders as identified by diagnostic criteria |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess rest and physical activity patterns in patients with advanced cancer |
Combined assessment using wrist and thigh accelerometry alongside a sleep and activity diary |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Baseline demographic details collected using a questionnaire |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Past medical history collected using a questionnaire |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Current medication use collected using a questionnaire |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer |
Chronotype assessed using the Morningness-Eveningness Questionnaire (MEQ) |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Occupation provided by participant using a questionnaire |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Number and timing of last cigarette smoked each day assessed using a patient diary |
During 72 hours period of monitoring |
|
| Secondary |
To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Number and timing of alcoholic beverages consumed each day assessed using a patient diary |
During 72 hours period of monitoring |
|
| Secondary |
To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer |
Number and timing of last of caffeinated drink consumed each day assessed using a patient diary |
During 72 hours period of monitoring |
|
| Secondary |
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms |
Symptoms measured using the Memorial Symptom Assessment Scale - Short Form (MSAS-SF) |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis |
Prognosis measured using the Prognosis in Palliative Care tool (PiPS-B) |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life |
Quality of Life measured using the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30) |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality |
Sleep quality measured using the brief Pittsburgh Sleep Quality Instrument (bPSQI) |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
| Secondary |
To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness |
Daytime sleepiness assess using the Epworth Sleepiness Scale |
Time 2 (after 72 consecutive hours of accelerometry monitoring) |
|
