Ignite Creation Date:
2024-05-05 @ 9:51 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00979888
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2009-09-17
Brief Title:
Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer
Sponsor:
University of Manchester
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This clinical trial is studying how caregivers help patients cope with respiratory and other symptoms caused by lung cancer
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 componentscharacteristics 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 eg 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 eg counseling aromatherapy with which they may be unfamiliar
PROJECTED ACCRUAL This study will accrue 30-40 pairs of patients and caregivers
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 componentscharacteristics 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 eg 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 eg counseling aromatherapy with which they may be unfamiliar
PROJECTED ACCRUAL This study will accrue 30-40 pairs of patients and caregivers
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20972 | None | None | None |
| UM-LC-Symptom-Clusters | None | None | None |