Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Pleural Effusion

Neoplasm Metastasis

Pleural Effusion, Malignant

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.

Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

talc

dyspnea management

Todd Demmy, MD

RATIONALE: It is not yet known whether pleurodesis using a chest tube with infusions of talc is more effective in improving quality of life than pleurodesis using a small catheter in treating malignant pleural effusion.

PURPOSE: Randomized phase III trial to compare the effectiveness of a chest tube and talc with that of a small catheter in treating malignant pleural effusion in patients who have cancer.

OBJECTIVES:

* Compare the success rate in patients with cancer who undergo pleurodesis using a standard chest tube with talc slurry vs a small (PleurX) catheter for the treatment of a symptomatic unilateral malignant pleural effusion.
* Compare the 30-day effusion control rate in patients treated with these procedures.
* Compare quality of life in these patients at 7-14 and 30-37 days after treatment with these procedures.
* Compare patient acceptance and satisfaction after treatment with these procedures.
* Compare the level of symptoms and dyspnea experienced by patients treated with these procedures.
* Compare the types, causes, and rates of early technical failures of these procedures in these patients.
* Compare the 30-day effusion recurrences in patients treated with these procedures.
* Compare the 60-day durability of pleurodesis in patients treated with these procedures.
* Compare the mortality, morbidity, and common surgical complications in patients treated with these procedures.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to inpatient status (yes vs no), disease type (breast vs lung vs other), and concurrent systemic chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo placement of a standard pleural chest tube. Within 36 hours of chest tube placement, patients undergo pleurodesis comprising intrapleural administration of talc slurry once followed by clamping of the chest tube for 2 hours while different patient positions are used to distribute the talc. The chest tube is then unclamped to allow continuous drainage. When the chest tube drainage is less than 150 mL over 24 hours, pleurodesis is assumed and the chest tube is removed.
* Arm II: Patients undergo pleurodesis comprising placement of a small (PleurX) catheter followed by pleural drainage for up to 90 minutes once daily. When the catheter drainage is less than 30 mL per day for 3 consecutive days, pleurodesis is assumed and the catheter is removed.

Quality of life and dyspnea are assessed at baseline and then at 7-14 and 30-37 days after treatment.

Patients are followed at 30 and 60 days.

Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer

Phase III Comparison of Catheter Based Therapy of Pleural Effusions in Cancer Patients (Optimal Pleural Effusion Control, OPEC)

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Behaviors and Mental Disorders

Rare Diseases

Anxiety Disorders

Depressive Disorder

Syndrome

Fatigue

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Depression

Lung Neoplasms

Dyspnea

Lung Diseases

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Respiration Disorders

Signs and Symptoms, Respiratory

Small Cell Lung Cancer

educational intervention

informational intervention

psychosocial support for caregiver

questionnaire administration

management of therapy complications

Alex Molassiotis, MD

RATIONALE: Gathering information about how patients, caregivers, and healthcare professionals cope with symptoms caused by lung cancer, such as breathlessness, cough, fatigue, anxiety, depression, pain, and difficulty sleeping, may help doctors learn more about non-drug methods of treating symptoms of respiratory distress.

PURPOSE: This clinical trial is studying how caregivers help patients cope with respiratory and other symptoms caused by lung cancer.

OBJECTIVES:

* To consolidate knowledge of existing interventions and their characteristics.
* To seek patients', caregivers', and healthcare professionals' views on existing interventions and to establish whether these groups utilize any additional interventions not currently described in the literature.
* To explore patients' perspectives on interrelationships among symptoms, in terms of clusters or causal relationships.
* To identify patients', caregivers', and healthcare professionals' views of the desirable components/characteristics of a novel intervention.
* Explore what is 'usual care' in the context of the study.

OUTLINE: This is a multicenter study.

The management of cough and breathlessness in respiratory diseases and lung cancer is assessed through a narrative review of interventions to support caregivers in providing physical care to patients with cancer and explore qualitative patient symptom experience with a particular focus on identifying specific characteristics and components of interventions and identifying patients' and caregivers' explanations of how the respiratory symptom cluster relates to other symptom experiences (e.g., fatigue, depression, anxiety).

Patients and caregivers undergo 2-3 face-to-face interviews to assess views on existing interventions in terms of perceived effectiveness, acceptability, importance, and feasibility; to establish whether additional interventions (formal or self-initiated) are employed; to address patient and caregiver experiences of symptom interactions and clusters; and to fine tune the content of the planned intervention and identify any synergies between symptoms as discussed by patients. Healthcare professionals undergo similar assessments via focus groups.

Patient and caregiver views on desirable components of a novel intervention are assessed by means of Discrete Choice Experiment (DCE) using a 'Best-Worst Scaling' (BWS) approach to allow identification of the relative importance of several attributes by means of a series of scenarios to enable a focus on characteristics of a nonpharmacological intervention, rather than requiring respondents to make judgments about the usefulness of specific interventions (e.g., counseling, aromatherapy) with which they may be unfamiliar.

PROJECTED ACCRUAL: This study will accrue 30-40 pairs of patients and caregivers.

Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer

A Non-pharmacological Supportive Care Intervention for Patients With Lung Cancer and Their Caregivers in the Management of the Respiratory Distress Symptom Cluster.

University of Manchester

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer	NCT00042770	Metastatic Canc... Pulmonary Compl...	talc dyspnea managem...	18 Years -	Alliance for Clinical Trials in Oncology
Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer	NCT00979888	Anxiety Disorde... Depression Dyspnea Fatigue Lung Cancer	educational int... informational i... psychosocial su... questionnaire a... dyspnea managem... management of t...	-	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for dyspnea management