Clinical trial NCT03981406: Palliative Care and Quality of Life in Idiopathic Pulmonary Fibrosis
Official title: The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Depression
Anxiety
Depressive Disorder
Anxiety Disorders
Anxiety Depression
Keywords: Palliative Care
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline respiratory quality of life as measured by SGRQ
timeFrame: 6 months
measure: Change from baseline anxiety and depression symptoms as measured by HADS
timeFrame: 6 months
measure: Change in prevalence of baseline depression as measured by PHQ-9
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline of spirometry
timeFrame: 6 months
measure: Change from baseline of diffusing capacity
timeFrame: 6 months
measure: Change from baseline of lung volume
timeFrame: 6 months
measure: Change from baseline of 6-minute walk distance
timeFrame: 6 months
measure: Total number of hospitalizations due to any cause
timeFrame: 6 months
measure: All-cause mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
citation: 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.