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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
Sponsor:
Collaborators:
The University of Western Australia
Edith Cowan University, Australia
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Information provided by (Responsible Party):
Dr. David Chi-leung Lam, The University of Hong Kong

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
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 Type : Observational
Estimated 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 : January 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Activity Behaviours (vertical axis movement counts per min) [ Time Frame: 7 days ]
    Recorded objectively by a triaxial accelerometer (ActiGraph GT3X+ Pensacola, FL, USA).

  2. 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

  3. 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.

  4. Survival (in number of days) [ Time Frame: 12 months ]
    Recorded from date of Actigraph initialization to death or 12-month, whichever comes first



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an MPE
Criteria

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.

Information from the National Library of Medicine

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


Locations
Hong Kong
University of Hong Kong Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: David CL Lam, PhD,MD    (852) 2255 5814    dcllam@hku.hk   
Principal Investigator: David CL Lam, PhD,MD         
Sub-Investigator: Macy MS Lui, MBBS         
Sponsors and Collaborators
The University of Hong Kong
The University of Western Australia
Edith Cowan University, Australia
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

Publications:

Responsible Party: Dr. David Chi-leung Lam, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03482570     History of Changes
Other Study ID Numbers: HKU_UW_17_516
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. David Chi-leung Lam, The University of Hong Kong:
Activity behaviors
Malignant pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms