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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00979888
First received: September 17, 2009
Last updated: August 23, 2013
Last verified: September 2009
  Purpose

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.


Condition Intervention
Anxiety Disorder
Depression
Dyspnea
Fatigue
Lung Cancer
Other: educational intervention
Other: informational intervention
Other: psychosocial support for caregiver
Other: questionnaire administration
Procedure: dyspnea management
Procedure: management of therapy complications

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Consolidation of knowledge of existing interventions and their characteristics [ Designated as safety issue: No ]
  • Patients', caregivers', and healthcare professionals' views on existing interventions [ Designated as safety issue: No ]
  • Utilization of any additional interventions not currently described in the literature [ Designated as safety issue: No ]
  • Exploration of patients' perspectives on interrelationships among symptoms, in terms of clusters or causal relationships [ Designated as safety issue: No ]
  • Patients', caregivers', and healthcare professionals' views of the desirable components/characteristics of a novel intervention using the Discrete Choice Experiment 'Best-Worst' scale [ Designated as safety issue: No ]
  • Exploration of what is 'usual care' in the context of the study [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979888

Locations
United Kingdom
University of Manchester Recruiting
Manchester, England, United Kingdom, M13 9PL
Contact: Alex Molassiotis, MD    44-161-306-7830      
Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Alex Molassiotis, MD University of Manchester
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00979888     History of Changes
Other Study ID Numbers: CDR0000649867, UM-LC-Symptom-Clusters, EU-20972
Study First Received: September 17, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
dyspnea
depression
fatigue
anxiety disorder
small cell lung cancer
non-small cell lung cancer

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Dyspnea
Fatigue
Lung Neoplasms
Mental Disorders
Behavioral Symptoms
Mood Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on July 24, 2014