Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Palliative Care
Eligibility Criteria
Inclusion Criteria:
- IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the patient's medical record
- Capacity to provide informed consent
Exclusion Criteria:
- Documented malignancy that would impact mortality within the study enrollment period
- Inability to pay for palliative care visit, insurance or personally.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Palliative Care
Standard of Care
Arm Description
Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings.
Standard of care for idiopathic pulmonary fibrosis
Outcomes
Primary Outcome Measures
Change from baseline respiratory quality of life as measured by SGRQ
The Saint George's Respiratory Questionnaire (SGRQ) is 50-item survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.
Change from baseline anxiety and depression symptoms as measured by HADS
The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.
Change in prevalence of baseline depression as measured by PHQ-9
The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.
Secondary Outcome Measures
Change from baseline of spirometry
Spirometry is a commonly-used pulmonary function test (PFT) measuring lung function. Greater spirometry output will be considered a measure of greater treatment efficacy.
Change from baseline of diffusing capacity
Diffusing capacity is a commonly-used pulmonary function test (PFT) measuring the transfer of gas from air in the lung to the red blood cells in lung blood vessels. Greater diffusing capacity will be considered a measure of greater treatment efficacy.
Change from baseline of lung volume
Lung volume is a commonly-used pulmonary function test (PFT) measuring the volume of inhaled or exhaled air. Greater lung volume will be considered a measure of greater treatment efficacy.
Change from baseline of 6-minute walk distance
6-minute walk distance will be considered as a measure of invention efficacy, with an increase in 6-minute walk distance considered a measure of greater treatment efficacy.
Total number of hospitalizations due to any cause
Total number of hospitalizations due to any cause will be considered as a measure of intervention efficacy, with decrease hospitalizations in the treatment group considered a measure of greater treatment efficacy.
All-cause mortality
All-cause mortality will be considered as a measure of intervention efficacy, with decrease in mortality in the treatment group considered a measure of greater treatment efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03981406
Brief Title
Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis
Official Title
The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effects of adding a palliative care intervention for patients with idiopathic pulmonary fibrosis (IPF) to current standard of care.
Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings. While the specific assistance and support provided by the Palliative Care Service depends on individual patient and family needs and preferences, it may include:
Pain and symptom management
Psychosocial and spiritual support
Assistance with treatment choices
Help in planning for care in the community
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a progressive and heterogeneous fibrotic lung disease. It is universally fatal, with an average time to death between two to five years.
Patients with IPF experience significantly diminished quality of life and increased symptom burden. Besides dyspnea, cough, fatigue, and deconditioning, patients with IPF experience significant depression and anxiety. The benefit of palliative care has been demonstrated in several other diseases, notably, in metastatic lung cancer. Patients with metastatic lung cancer who were seen by palliative care at the time of their diagnosis and throughout their disease course were found to have increased survival, improved quality of life, and received less aggressive care at the end of their life. This finding has prompted significant research in the role of palliative care in other diseases, including chronic lung disease. A non-blinded, randomized trial of a multi-disciplinary breathlessness service intervention in patients with advanced disease including cancer, chronic obstructive lung disease (COPD), interstitial lung disease (ILD), and congestive heart failure demonstrated improvement in breathlessness, anxiety, and even survival. Specific Aim 1: Determine if quality of life is improved with a palliative care intervention. Specific Aim 2: Determine if depression and anxiety symptoms are decreased with a palliative care intervention. Secondary aims include an examination of pulmonary function tests (PFT), number of hospitalizations, and overall mortality as an effect of a palliative care intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Depression, Anxiety, Depressive Disorder, Anxiety Disorders, Anxiety Depression
Keywords
Palliative Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palliative Care
Arm Type
Experimental
Arm Description
Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings.
Arm Title
Standard of Care
Arm Type
Placebo Comparator
Arm Description
Standard of care for idiopathic pulmonary fibrosis
Intervention Type
Behavioral
Intervention Name(s)
Palliative Care
Intervention Description
The intervention is one visit to the Fairview Clinics and Surgery Center palliative care clinic, with follow up visits as determined by the palliative care team and the patient.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Control group will receive standard of care treatment for IPF.
Primary Outcome Measure Information:
Title
Change from baseline respiratory quality of life as measured by SGRQ
Description
The Saint George's Respiratory Questionnaire (SGRQ) is 50-item survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.
Time Frame
6 months
Title
Change from baseline anxiety and depression symptoms as measured by HADS
Description
The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.
Time Frame
6 months
Title
Change in prevalence of baseline depression as measured by PHQ-9
Description
The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline of spirometry
Description
Spirometry is a commonly-used pulmonary function test (PFT) measuring lung function. Greater spirometry output will be considered a measure of greater treatment efficacy.
Time Frame
6 months
Title
Change from baseline of diffusing capacity
Description
Diffusing capacity is a commonly-used pulmonary function test (PFT) measuring the transfer of gas from air in the lung to the red blood cells in lung blood vessels. Greater diffusing capacity will be considered a measure of greater treatment efficacy.
Time Frame
6 months
Title
Change from baseline of lung volume
Description
Lung volume is a commonly-used pulmonary function test (PFT) measuring the volume of inhaled or exhaled air. Greater lung volume will be considered a measure of greater treatment efficacy.
Time Frame
6 months
Title
Change from baseline of 6-minute walk distance
Description
6-minute walk distance will be considered as a measure of invention efficacy, with an increase in 6-minute walk distance considered a measure of greater treatment efficacy.
Time Frame
6 months
Title
Total number of hospitalizations due to any cause
Description
Total number of hospitalizations due to any cause will be considered as a measure of intervention efficacy, with decrease hospitalizations in the treatment group considered a measure of greater treatment efficacy.
Time Frame
6 months
Title
All-cause mortality
Description
All-cause mortality will be considered as a measure of intervention efficacy, with decrease in mortality in the treatment group considered a measure of greater treatment efficacy.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the patient's medical record
Capacity to provide informed consent
Exclusion Criteria:
Documented malignancy that would impact mortality within the study enrollment period
Inability to pay for palliative care visit, insurance or personally.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31900187
Citation
Janssen K, Rosielle D, Wang Q, Kim HJ. The impact of palliative care on quality of life, anxiety, and depression in idiopathic pulmonary fibrosis: a randomized controlled pilot study. Respir Res. 2020 Jan 3;21(1):2. doi: 10.1186/s12931-019-1266-9.
Results Reference
derived
Learn more about this trial
Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis
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