Clinical trial NCT03482570: Activity Behaviours in Patients With Malignant Pleural Effusion
Official title: Activity Behaviours in Patients With Malignant Pleural Effusion: Relationships With Quality of Life, and Respiratory Symptoms, and Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Effusion
Keywords: Activity behaviors
Malignant pleural effusion
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Western Australia
name: Edith Cowan University
name: Queen Elizabeth Hospital, Hong Kong
name: Princess Margaret Hospital, Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2018-03-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an MPE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Activity Behaviours (vertical axis movement counts per min)
timeFrame: 7 days
measure: Quality of life (in mm)
timeFrame: 7 days
measure: Respiratory symptoms (in mm)
timeFrame: 7 days
measure: Survival (in number of days)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong Queen Mary Hospital
Study officials:
affiliation: University of Hong Kong Queen Mary Hospital
name: David CL Lam, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.
citation: Thomas R, Francis R, Davies HE, Lee YC. Interventional therapies for malignant pleural effusions: the present and the future. Respirology. 2014 Aug;19(6):809-22. doi: 10.1111/resp.12328. Epub 2014 Jun 19.
citation: Owen N. Sedentary behavior: understanding and influencing adults' prolonged sitting time. Prev Med. 2012 Dec;55(6):535-9. doi: 10.1016/j.ypmed.2012.08.024. Epub 2012 Sep 8.
citation: Kelly LA, McMillan DG, Anderson A, Fippinger M, Fillerup G, Rider J. Validity of actigraphs uniaxial and triaxial accelerometers for assessment of physical activity in adults in laboratory conditions. BMC Med Phys. 2013 Nov 26;13(1):5. doi: 10.1186/1756-6649-13-5.
citation: Van Remoortel H, Giavedoni S, Raste Y, Burtin C, Louvaris Z, Gimeno-Santos E, Langer D, Glendenning A, Hopkinson NS, Vogiatzis I, Peterson BT, Wilson F, Mann B, Rabinovich R, Puhan MA, Troosters T; PROactive consortium. Validity of activity monitors in health and chronic disease: a systematic review. Int J Behav Nutr Phys Act. 2012 Jul 9;9:84. doi: 10.1186/1479-5868-9-84.
citation: Jeffery E, Lee YG, McVeigh J, Straker L, Wooding T, Newton RU, Peddle-McIntyre C. Feasibility of objectively measured physical activity and sedentary behavior in patients with malignant pleural effusion. Support Care Cancer. 2017 Oct;25(10):3133-3141. doi: 10.1007/s00520-017-3721-9. Epub 2017 Apr 28.
citation: Vallance JK, Boyle T, Courneya KS, Lynch BM. Associations of objectively assessed physical activity and sedentary time with health-related quality of life among colon cancer survivors. Cancer. 2014 Sep 15;120(18):2919-26. doi: 10.1002/cncr.28779. Epub 2014 Jun 4.
citation: Solberg Nes L, Liu H, Patten CA, Rausch SM, Sloan JA, Garces YI, Cheville AL, Yang P, Clark MM. Physical activity level and quality of life in long term lung cancer survivors. Lung Cancer. 2012 Sep;77(3):611-6. doi: 10.1016/j.lungcan.2012.05.096. Epub 2012 Jun 6.
citation: Sloan JA, Cheville AL, Liu H, Novotny PJ, Wampfler JA, Garces YI, Clark MM, Yang P. Impact of self-reported physical activity and health promotion behaviors on lung cancer survivorship. Health Qual Life Outcomes. 2016 Apr 29;14:66. doi: 10.1186/s12955-016-0461-3.
citation: Lynch BM, Cerin E, Owen N, Hawkes AL, Aitken JF. Prospective relationships of physical activity with quality of life among colorectal cancer survivors. J Clin Oncol. 2008 Sep 20;26(27):4480-7. doi: 10.1200/JCO.2007.15.7917.
citation: Canario AC, Cabral PU, de Paiva LC, Florencio GL, Spyrides MH, Goncalves AK. Physical activity, fatigue and quality of life in breast cancer patients. Rev Assoc Med Bras (1992). 2016 Jan-Feb;62(1):38-44. doi: 10.1590/1806-9282.62.01.38.
citation: Beesley VL, Price MA, Butow PN, Green AC, Olsen CM; Australian Ovarian Cancer Study Group; Australian Ovarian Cancer Study - Quality of Life Study Investigators; Webb PM. Physical activity in women with ovarian cancer and its association with decreased distress and improved quality of life. Psychooncology. 2011 Nov;20(11):1161-9. doi: 10.1002/pon.1834. Epub 2010 Aug 26.
citation: Cheville AL, Novotny PJ, Sloan JA, Basford JR, Wampfler JA, Garces YI, Jatoi A, Yang P. The value of a symptom cluster of fatigue, dyspnea, and cough in predicting clinical outcomes in lung cancer survivors. J Pain Symptom Manage. 2011 Aug;42(2):213-21. doi: 10.1016/j.jpainsymman.2010.11.005. Epub 2011 Mar 12.
citation: O'Driscoll M, Corner J, Bailey C. The experience of breathlessness in lung cancer. Eur J Cancer Care (Engl). 1999 Mar;8(1):37-43. doi: 10.1046/j.1365-2354.1999.00129.x.
citation: Fysh ET, Thomas R, Read CA, Kwan BC, Yap E, Horwood FC, Lee P, Piccolo F, Shrestha R, Garske LA, Lam DC, Rosenstengel A, Bint M, Murray K, Smith NA, Lee YC. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis. BMJ Open. 2014 Nov 6;4(11):e006757. doi: 10.1136/bmjopen-2014-006757.
citation: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
citation: Light RW, Rogers JT, Cheng D, Rodriguez RM. Large pleural effusions occurring after coronary artery bypass grafting. Cardiovascular Surgery Associates, PC. Ann Intern Med. 1999 Jun 1;130(11):891-6. doi: 10.7326/0003-4819-130-11-199906010-00004.