A Quality of Life Study re Management of Malignant Pleural Effusions

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00188474

Enrollment

149

Registered

2005-09-16

Start date

2004-08-31

Completion date

2013-11-30

Last updated

2017-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Effusions

Brief 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.

Detailed 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

Interventions

BEHAVIORALLCADLS, FACIT-PAL, FACIT-TS questionnaires

LCADLS, FACIT-PAL, FACIT-TS questionnaires

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026