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Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Anxiety Depression
Depression
Anxiety Disorders
Anxiety
Idiopathic Pulmonary Fibrosis
Depressive Disorder

Treatments

Behavioral: Standard of Care
Behavioral: Palliative Care

Study type

Interventional

Funder types

Other

Identifiers

NCT03981406
STUDY00000753

Details and patient eligibility

About

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

Full 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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups, including a placebo group

Palliative Care
Experimental group
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.
Treatment:
Behavioral: Palliative Care
Standard of Care
Placebo Comparator group
Description:
Standard of care for idiopathic pulmonary fibrosis
Treatment:
Behavioral: Standard of Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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