Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer
Recruitment status was: Recruiting
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.
Other: educational intervention
Other: informational intervention
Other: psychosocial support for caregiver
Other: questionnaire administration
Procedure: dyspnea management
Procedure: management of therapy complications
|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.|
- 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 ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979888
|University of Manchester|
|Manchester, England, United Kingdom, M13 9PL|
|Principal Investigator:||Alex Molassiotis, MD||University of Manchester|