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

City of Hope

Status: Completed

Conditions: Lung Cancer

Treatments: Other: educational intervention; Procedure: quality-of-life assessment; Procedure: psychosocial assessment and care; Other: questionnaire administration; Procedure: end-of-life treatment/management; Other: medical chart review

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00823667

CDR0000631255 (Registry Identifier)

08034

P30CA033572 (U.S. NIH Grant/Contract)

CHNMC-08034

P01CA136396 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Phase 1 Usual care

Active Comparator group

Treatment:

Other: medical chart review

Other: questionnaire administration

Procedure: end-of-life treatment/management

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care

Phase 2 Intervention

Active Comparator group

Treatment:

Other: medical chart review

Other: questionnaire administration

Procedure: end-of-life treatment/management

Other: educational intervention

Procedure: quality-of-life assessment

Procedure: psychosocial assessment and care