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
NCT ID: NCT00823667
Last Updated: 2014-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2009-09-30
2014-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Phase 1 Usual care
medical chart review
Occurs at 1 year post study enrollment
questionnaire administration
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
end-of-life treatment/management
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
psychosocial assessment and care
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
quality-of-life assessment
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
Phase 2 Intervention
educational intervention
Palliative care intervention at weeks 3,4,5 and 6 post study enrollment
medical chart review
Occurs at 1 year post study enrollment
questionnaire administration
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
end-of-life treatment/management
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
psychosocial assessment and care
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
quality-of-life assessment
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
Interventions
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educational intervention
Palliative care intervention at weeks 3,4,5 and 6 post study enrollment
medical chart review
Occurs at 1 year post study enrollment
questionnaire administration
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
end-of-life treatment/management
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
psychosocial assessment and care
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
quality-of-life assessment
Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
Eligibility Criteria
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Inclusion Criteria
* Living within a 50 mile radius of the City of Hope
* No previous cancer within the past 5 years
Exclusion Criteria
* NSCLC patients receiving radiofrequency ablation
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Betty Ferrell, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Comprehensive Cancer Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Countries
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References
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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.
Other Identifiers
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CHNMC-08034
Identifier Type: -
Identifier Source: secondary_id
CDR0000631255
Identifier Type: REGISTRY
Identifier Source: secondary_id
08034
Identifier Type: -
Identifier Source: org_study_id
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