Clinical trial NCT00823667: Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer That Can Be Removed by Surgery
Official title: Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-15
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer.

PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage I, stage II, or stage IIIA non-small cell lung cancer that can be removed by surgery.

Detailed description: OBJECTIVES:

* To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with resectable stage I-IIIA non-small cell lung cancer.
* To compare symptom control in these patients.
* To compare geriatric assessment outcomes, as measured by OARS (Older Americans Resources and Services) Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS (Medical Outcomes Study)Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients.
* To compare the effects of the PCI vs standard care on resource use.
* To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12.

OUTLINE: Patients assigned to 1 of 2 groups.

* Group I (standard care): Patients receive standard care. Patients complete questionnaires at baseline and at 6, 12, 24, 36, and 52 weeks to evaluate quality of life (QOL), symptoms, psychological distress, and geriatric assessments. A medical chart review is performed at 52 weeks to assess the progression of treatment, episodes of care, and re-admissions.
* Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention combining patient-centered teaching principles and concepts that are learner-centered (builds on the strengths, interests, and needs of the learner), knowledge-centered (teacher is proficient in the content being taught), assessment-centered (learners are given an opportunity to test their understanding and receive feedback), and community-centered (opportunities are available for continued learning and support). Patients undergo 4 teaching sessions (based on the patient-centered teaching principles and concepts) that focus on physical, psychological, social, and spiritual well-being, respectively, once a week in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9-21 to clarify questions or review concerns from the teaching sessions and to coordinate follow-up resources as needed. Patients also complete questionnaires as in group I.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage I-IIIA resectable NSCLC - Undergoing either lobectomy, pneumonectomy, segmentectomy, or wedge resection
* Living within a 50 mile radius of the City of Hope
* No previous cancer within the past 5 years

Exclusion Criteria:

* Diagnosis of stage II-III NSCLC that are not resectable based on clinical and individual characteristics (co-morbidities, extent of disease, bulky mediastinal lymph nodes \[N2\], etc.)
* NSCLC patients receiving radiofrequency ablation

Primary outcomes:
measure: Overall quality of life and psychological distress
timeFrame: 1 year after study enrollment
measure: Symptom control
timeFrame: 1 year after study enrollment
measure: Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale
timeFrame: 1 year after study enrollment
measure: Resource use as measured by chart audits
timeFrame: 1 year after study enrollment
measure: Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12
timeFrame: Week 12 after study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Betty Ferrell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JY, Sun V, Raz DJ, Williams AC, Fujinami R, Reckamp K, Koczywas M, Cristea M, Hurria A, Ferrell B. The impact of lung cancer surgery on quality of life trajectories in patients and family caregivers. Lung Cancer. 2016 Nov;101:35-39. doi: 10.1016/j.lungcan.2016.08.011. Epub 2016 Aug 30.