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Clinical Trials (PDQ®)

  • First Published: 9/16/2009

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Clinical Trials (PDQ®)

Study of Nonpharmacological Management of Respiratory Distress Symptom Cluster Performed by Patients' Caregivers in Patients With Lung Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedHealth services research, Supportive careUnknownNot specifiedOtherUM-LC-Symptom-Clusters
UM-LC-Symptom Clusters, EU-20972, NCT00979888

Objectives

  1. To consolidate knowledge of existing interventions and their characteristics.
  2. 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.
  3. To explore patients’ perspectives on interrelationships among symptoms, in terms of clusters or causal relationships.
  4. To identify patients’, caregivers', and healthcare professionals’ views of the desirable components/characteristics of a novel intervention.
  5. Explore what is ‘usual care’ in the context of the study.

Entry Criteria

Disease Characteristics:

  • Meets 1 of the following criteria:
    • Patient with diagnosis of lung cancer
    • Caregiver of patient
    • Healthcare professional (i.e., clinical nurse specialist, physiotherapist, primary care team member, or palliative care team member)

  • Patients recruited from Manchester, Liverpool, or Southampton hospitals

Prior/Concurrent Therapy:

  • Not specified

Patient Characteristics:

  • Not specified

Expected Enrollment

80

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

Outcomes

Primary Outcome(s)

Consolidation of knowledge of existing interventions and their characteristics
Patients’, caregivers’, and healthcare professionals’ views on existing interventions
Utilization of any additional interventions not currently described in the literature
Exploration of patients’ perspectives on interrelationships among symptoms, in terms of clusters or causal relationships
Patients’, caregivers’, and healthcare professionals’ views of the desirable components/characteristics of a novel intervention using the Discrete Choice Experiment 'Best-Worst' scale
Exploration of 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.

Trial Contact Information

Trial Lead Organizations

University of Manchester

Alex Molassiotis, MD, Principal investigator
Ph: 44-161-306-7830

Registry Information
Official Title A non-pharmacological supportive care intervention for patients with lung cancer and their caregivers in the management of the respiratory distress symptom cluster.
Trial Start Date 2009-07-30
Trial Completion Date 2010-07-30 (estimated)
Registered in ClinicalTrials.gov NCT00979888
Date Submitted to PDQ 2009-07-15
Information Last Verified 2009-09-16

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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