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NCT Number: NCT03981406

Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Anxiety Anxiety Depression Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Lung Diseases Lung Diseases, Interstitial Mental Disorders Mood Disorders Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palliative Care

Behavioral

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.

Standard of Care

Behavioral

Control group will receive standard of care treatment for IPF.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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