NCT00979888

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

August 26, 2013

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

September 17, 2009

Last Update Submit

August 23, 2013

Conditions

Keywords

dyspneadepressionfatigueanxiety disordersmall cell lung cancernon-small cell lung cancer

Outcome Measures

Primary Outcomes (6)

  • 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

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, England, M13 9PL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionDyspneaFatigueLung NeoplasmsSmall Cell Lung CarcinomaCarcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, EducationalPsychiatric RehabilitationCaregivers

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitationTherapeuticsHealth Personnel

Study Officials

  • Alex Molassiotis, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Last Updated

August 26, 2013

Record last verified: 2009-09

Locations