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

August 23, 2013 updated by: University of Manchester

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M13 9PL
        • Recruiting
        • University of Manchester
        • Contact:
          • Alex Molassiotis, MD
          • Phone Number: 44-161-306-7830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000649867
  • UM-LC-Symptom-Clusters
  • EU-20972

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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