Activity Behaviours in Patients With Malignant Pleural Effusion

Sponsor

The University of Hong Kong (Other)

Overall Status

Unknown status

CT.gov ID

NCT03482570

Collaborator

The University of Western Australia (Other), Edith Cowan University (Other), Queen Elizabeth Hospital, Hong Kong (Other), Princess Margaret Hospital, Hong Kong (Other), Prince of Wales Hospital, Shatin, Hong Kong (Other)

200

Enrollment

Location

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Pleural Effusion	Device: ActiGraph

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Activity Behaviours in Patients With Malignant Pleural Effusion: Relationships With Quality of Life, and Respiratory Symptoms, and Survival

Actual Study Start Date :

Jan 31, 2018

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Activity Behaviours (vertical axis movement counts per min) [7 days]
Recorded objectively by a triaxial accelerometer (ActiGraph GT3X+ Pensacola, FL, USA).
Quality of life (in mm) [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) [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) [12 months]
Recorded from date of Actigraph initialization to death or 12-month, whichever comes first

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with an MPE (i.e. one in which malignant cells are identified in the pleural fluid or pleural biopsy); or a large exudative pleural effusion without other causes in a patient with known disseminated extra-thoracic malignancy

Exclusion Criteria:

Patients with Age <18 years; pleural infection; pregnant or lactating; inability to consent or comply with the protocol; anticipated pleural drainage procedure within one week subsequent to recruitment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hong Kong Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

The University of Hong Kong
The University of Western Australia
Edith Cowan University
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong

Investigators

Principal Investigator: David CL Lam, PhD, MD, University of Hong Kong Queen Mary Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Dr. David Chi-leung Lam, Clinical Associate Professor, The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT03482570

Other Study ID Numbers:

HKU_UW_17_516

First Posted:

Mar 29, 2018

Last Update Posted:

Apr 2, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. David Chi-leung Lam, Clinical Associate Professor, The University of Hong Kong

Activity behaviors

Malignant pleural effusion

Additional relevant MeSH terms:

Pleural Effusion, Malignant

Pleural Effusion

Study Results

No Results Posted as of Apr 2, 2018