A Quality of Life Study re Management of Malignant Pleural Effusions

Malignant Pleural Effusions Clinical Trial

Official title:

A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188474
• Other study ID #: 04-0233-CE
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 3, 2017
• Start date: August 2004
• Est. completion date: November 2013

Study information

• Verified date: May 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

There is much data in the literature regarding optimal treatment approaches for malignant pleural effusions as assessed by patient outcomes. However, data on quality of life and satisfaction with treatment from the patient's perspective is not available.

Description:

This study will compare various treatment strategies in the management of malignant pleural effusions with respect to:

1. Primary endpoint: the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)

2. Secondary endpoints:

i) impact of treatment on patient quality of life as assessed by the Functional Assessment of Chronic Illness Therapy - Palliative patient (FACIT-PAL) questionnaire ii) Assessment of patient satisfaction with treatment received via Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction (FACIT-TS) questionnaire iii)Pleurodesis success rates assessed by 2 and 6-week effusion control rates on CXR iv) Requirement of further hospitalizations or procedures for the treatment of recurrent effusions v) Comparison of morbidity and mortality rates for differing treatment approaches vi) comparison of cost in a Canadian health care setting for differing treatment approaches

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic pleural effusion

• history of malignant disease

• age greater that 18 years

• consent to participate in study

Exclusion Criteria:

• significant ipsilateral endobronchial disease

• prior ipsilateral, intra-pleural therapy, as defined by: prior chest tube placement for effusion, prior attempt at chemical/surgical pleurodesis, prior surgical pleurectomy

• active pulmonary or pleural infection

• granulocytes < 1500/mm3, platelets < 50,000/mm3

• systemic chemotherapy within 2 weeks

• allergy to talc

Related Conditions & MeSH terms

• Malignant Pleural Effusions
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Behavioral:
• LCADLS, FACIT-PAL, FACIT-TS questionnaires
LCADLS, FACIT-PAL, FACIT-TS questionnaires

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the successful palliation of symptomatic pleural effusions as assessed by the London Chest Activity of Daily Living Scale (LCADLS)		discharge, 2 wks and 6 wks