Anxiety DisorderNCT00979888
Study of How Caregivers Help Patients Cope With Respiratory and Other Symptoms Caused by Lung Cancer
A study testing educational intervention, informational intervention and psychosocial support for caregiver in people with Anxiety Disorder and Depression, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety Disorder, Depression, Dyspnea
- What is being tested?
- educational intervention, informational intervention and psychosocial support for caregiver
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Manchester
Manchester, England, M13 9PL
Alex Molassiotis, MD, 44-161-306-7830
About this study
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.
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.
Read the 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.
- Conditions
- Anxiety Disorder, Depression, Dyspnea, Fatigue, Lung Cancer
- Being tested
- educational intervention, informational intervention, psychosocial support for caregiver, questionnaire administration, dyspnea management
- Keywords
- dyspnea, depression, fatigue, anxiety disorder, small cell lung cancer, non-small cell lung cancer
- Medical subject headings
- Anxiety Disorders, Depression, Dyspnea, Fatigue, Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
informational interventionOther
psychosocial support for caregiverOther
questionnaire administrationOther
dyspnea managementProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Investigators
- Alex Molassiotis, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979888
- Sponsor's protocol ID
- CDR0000649867
- Other IDs
- UM-LC-Symptom-Clusters, EU-20972
- Status last verified
- Sep 2009
- First submitted
- 17 Sep 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00979888
- Acronym / sponsor ID
- CDR0000649867
- Conditions
- Anxiety Disorder, Depression, Dyspnea, Fatigue, Lung Cancer
- Keywords
- dyspnea, depression, fatigue, anxiety disorder, small cell lung cancer, non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (estimated)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention | Other | – |
| informational intervention | Other | – |
| psychosocial support for caregiver | Other | – |
| questionnaire administration | Other | – |
| dyspnea management | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Molassiotis, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, informational intervention and psychosocial support for caregiver in people with Anxiety Disorder and Depression, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consolidation of knowledge of existing interventions and their characteristics. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.