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

Depression Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00979888
• Other study ID #: CDR0000649867
• Secondary ID: UM-LC-Symptom-Cl
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2009
• Last updated: August 23, 2013
• Start date: July 2009

Study information

• Verified date: September 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Dyspnea
• Fatigue
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• educational intervention

• informational intervention

• psychosocial support for caregiver

• questionnaire administration

Procedure:
• dyspnea management

• management of therapy complications

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consolidation of knowledge of existing interventions and their characteristics			No
Primary	Patients', caregivers', and healthcare professionals' views on existing interventions			No
Primary	Utilization of any additional interventions not currently described in the literature			No
Primary	Exploration of patients' perspectives on interrelationships among symptoms, in terms of clusters or causal relationships			No
Primary	Patients', caregivers', and healthcare professionals' views of the desirable components/characteristics of a novel intervention using the Discrete Choice Experiment 'Best-Worst' scale			No
Primary	Exploration of what is 'usual care' in the context of the study			No