An observational study in Malignant Pleural Effusion, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-02.
Sponsored by The University of Hong Kong · Observational
The purpose of this research is to objectively assess activity behaviours (i.e., physical activity and sedentary behaviour) in patients with malignant pleural effusion. First, we aim to describe the physical activity and sedentary behavior of patients with MPE in Hong Kong. Secondarily, we aim to assess the relationships between activity behaviours and survival, quality of life, and respiratory symptoms e.g. shortness of breath.
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.
169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.
This study's planned enrollment of 200 is above the median of 112 across 37 observational studies indexed under Pleural Effusion, Malignant.
Browse Pleural Effusion, Malignant studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with an MPE
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Recorded objectively by a triaxial accelerometer (ActiGraph GT3X+ Pensacola, FL, USA).
Time frame: 7 days
Quality of life (in mm)
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
Time frame: 7 days
Respiratory symptoms (in mm)
Assessed by a 100 mm visual analogue scale with "no breathlessness" at 0 mm and "worst breathlessness imaginable" at 100 mm.
Time frame: 7 days
Survival (in number of days)
Recorded from date of Actigraph initialization to death or 12-month, whichever comes first
Time frame: 12 months
Plan to share: No
Started Jan 2018 (actual). Primary completion is estimated for Dec 2019, 23 months after the start.
Of 22 observational studies under Pleural Effusion, Malignant, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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