Activity Behaviours in Patients With Malignant Pleural Effusion
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|ClinicalTrials.gov Identifier: NCT03482570|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment|
|Malignant Pleural Effusion||Device: ActiGraph|
The development of a malignant pleural effusion (MPE) can be a consequence of metastatic spread of any cancer, but most commonly lung, breast and gynecological cancers or from primary pleural neoplasms (e.g., mesothelioma). The presence of MPE represents incurable disease and median survival ranges from 3 to 12 months from first presentation. Breathlessness is a common and debilitating symptom reported by this patient group and interventions are aimed at managing symptoms for optimal quality of life.
Breathlessness and other symptoms that result from MPE are likely to limit a person's ability to be physically active. Activity behaviours encompasses physical activity behaviour (i.e., low intensity physical activity and moderate-to-vigorous physical activity) and sedentary behaviour (i.e., sitting or reclining activities low in energy expenditure) accumulated during waking hours. Performance status measures are routinely used in cancer populations and are largely based on self-reported activity behaviors. While performance status is a reliable predictor of survival in patients with MPE, such measures are subjective, broad and significantly, can differ between patients and clinicians. Measures of performance status may fail to detect small, but meaningful changes in activity behaviours. Objective assessment of activity behaviours using accelerometers could provide a more reliable and sensitive method to assess physical activity and sedentary behaviour, particularly in advanced cancer populations. Objective assessment of activity behaviours using accelerometers has been demonstrated to accurately measure physical activity when compared to oxygen consumption. Triaxial accelerometry is considered the most accurate assessment for physical activity in chronic disease populations.
Preliminary research in patients with MPE indicates that patients have very low activity levels. Participants with MPE spent more that 70% of waking hours sedentary (i.e., activities of very low energy expenditure, sitting or lying down). Those patients with MPE with the best performance status and longest survival were significantly more active and less sedentary than those with a poor performance status and limited survival. However, these preliminary results require replication. Further, it is not yet known if activity behaviours are associated with quality of life or symptoms such as dyspnea in this patient population. Evidence from other cancer survivor populations suggests that activity behaviours are linked to quality of life and symptoms. In patients with breast, colorectal, lung and ovarian cancer, those that are more physically active report better quality of life. In patients with lung cancer, symptoms such as breathlessness and fatigue appear to be associated with lower physical activity levels.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Activity Behaviours in Patients With Malignant Pleural Effusion: Relationships With Quality of Life, and Respiratory Symptoms, and Survival|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
- Device: ActiGraph
Activity behaviours will be objectively assessed by 7-day triaxial accelerometer assessment (ActiGraph GT3X+ Pensacola, FL, USA). Participants will be asked to wear an accelerometer around their waist, 24 hours a day for 7 days.
- Activity Behaviours (vertical axis movement counts per min) [ Time Frame: 7 days ]Recorded objectively by a triaxial accelerometer (ActiGraph GT3X+ Pensacola, FL, USA).
- Quality of life (in mm) [ Time Frame: 7 days ]Assessed by a 100 mm visual analogue scale with "the best imaginable health state" at 0 mm and "the worst imaginable health state" at 100 mm
- Respiratory symptoms (in mm) [ Time Frame: 7 days ]Assessed by a 100 mm visual analogue scale with "no breathlessness" at 0 mm and "worst breathlessness imaginable" at 100 mm.
- Survival (in number of days) [ Time Frame: 12 months ]Recorded from date of Actigraph initialization to death or 12-month, whichever comes first
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482570
|University of Hong Kong Queen Mary Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: David CL Lam, PhD,MD (852) 2255 5814 firstname.lastname@example.org|
|Principal Investigator: David CL Lam, PhD,MD|
|Sub-Investigator: Macy MS Lui, MBBS|
|Principal Investigator:||David CL Lam, PhD, MD||University of Hong Kong Queen Mary Hospital|