Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Depressive Disorder; Anxiety Depression; Depression; Idiopathic Pulmonary Fibrosis; Anxiety; Anxiety Disorders
• Interventions: Behavioral: Standard of Care; Behavioral: Palliative Care

• Registration Number: NCT03981406
• Lead Sponsor: University of Minnesota

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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Exclusion Criteria

• Documented malignancy that would impact mortality within the study enrollment period
• Inability to pay for palliative care visit, insurance or personally.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of care for idiopathic pulmonary fibrosis
Palliative Care	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline respiratory quality of life as measured by SGRQ	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.
Change from baseline anxiety and depression symptoms as measured by HADS	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.
Change in prevalence of baseline depression as measured by PHQ-9	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

Name	Time	Method
Change from baseline of diffusing capacity	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.
All-cause mortality	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.
Change from baseline of lung volume	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.
Change from baseline of 6-minute walk distance	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.
Change from baseline of spirometry	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.
Total number of hospitalizations due to any cause	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States