Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis

NCT ID: NCT03981406

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-03-01

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.

Conditions

Idiopathic Pulmonary Fibrosis; Depression; Anxiety; Depressive Disorder; Anxiety Disorders; Anxiety Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palliative Care

Intervention Type: 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

Standard of care for idiopathic pulmonary fibrosis

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Control group will receive standard of care treatment for IPF.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care

Control group will receive standard of care treatment for IPF.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31900187 (View on PubMed)

Other Identifiers

STUDY00000753

Identifier Type: -

Identifier Source: org_study_id