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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Other: medical chart review; Other: educational intervention; Other: questionnaire administration; Procedure: end-of-life treatment/management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

• Registration Number: NCT00823667
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Study Start: 2009-09
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 1 Usual care	questionnaire administration	-
Phase 1 Usual care	end-of-life treatment/management	-
Phase 1 Usual care	psychosocial assessment and care	-
Phase 1 Usual care	quality-of-life assessment	-
Phase 2 Intervention	quality-of-life assessment	-
Phase 2 Intervention	end-of-life treatment/management	-
Phase 1 Usual care	medical chart review	-
Phase 2 Intervention	medical chart review	-
Phase 2 Intervention	questionnaire administration	-
Phase 2 Intervention	educational intervention	-
Phase 2 Intervention	psychosocial assessment and care	-

Primary Outcome Measures

Name	Time	Method
Resource use as measured by chart audits	1 year after study enrollment
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	1 year after study enrollment
Overall quality of life and psychological distress	1 year after study enrollment
Symptom control	1 year after study enrollment
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	Week 12 after study enrollment

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States