Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
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.
Interventions
OTHEReducational intervention
Palliative care intervention at weeks 3,4,5 and 6 post study enrollment
OTHERmedical chart review
Occurs at 1 year post study enrollment
OTHERquestionnaire administration
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
PROCEDUREend-of-life treatment/management
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
PROCEDUREpsychosocial assessment and care
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
PROCEDUREquality-of-life assessment
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall quality of life and psychological distress | 1 year after study enrollment |
| Symptom control | 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 |
| Resource use as measured by chart audits | 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 |
Countries
United States
Outcome results
None listed