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Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03981406
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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:

  1. Pain and symptom management
  2. Psychosocial and spiritual support
  3. Assistance with treatment choices
  4. Help in planning for care in the community

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Depression Anxiety Depressive Disorder Anxiety Disorders Anxiety Depression Behavioral: Palliative Care Behavioral: Standard of Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019


Arm Intervention/treatment
Experimental: Palliative 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.
Behavioral: Palliative Care
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.

Placebo Comparator: Standard of Care
Standard of care for idiopathic pulmonary fibrosis
Behavioral: Standard of Care
Control group will receive standard of care treatment for IPF.




Primary Outcome Measures :
  1. Change from baseline respiratory quality of life as measured by SGRQ [ Time Frame: 6 months ]
    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.

  2. Change from baseline anxiety and depression symptoms as measured by HADS [ Time Frame: 6 months ]
    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.

  3. Change in prevalence of baseline depression as measured by PHQ-9 [ Time Frame: 6 months ]
    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 :
  1. Change from baseline of spirometry [ Time Frame: 6 months ]
    Spirometry is a commonly-used pulmonary function test (PFT) measuring lung function. Greater spirometry output will be considered a measure of greater treatment efficacy.

  2. Change from baseline of diffusing capacity [ Time Frame: 6 months ]
    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.

  3. Change from baseline of lung volume [ Time Frame: 6 months ]
    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.

  4. Change from baseline of 6-minute walk distance [ Time Frame: 6 months ]
    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.

  5. Total number of hospitalizations due to any cause [ Time Frame: 6 months ]
    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.

  6. All-cause mortality [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981406


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03981406     History of Changes
Other Study ID Numbers: STUDY00000753
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Palliative Care
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Disease
Fibrosis
Anxiety Disorders
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial