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.
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
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
England
-
Manchester, England, United Kingdom, M13 9PL
- Recruiting
- University of Manchester
-
Contact:
- Alex Molassiotis, MD
- Phone Number: 44-161-306-7830
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.